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Articles in category: Research & Development

8 Orthopedic Companies New on Our Radar

by Julie A. Vetalice | Apr 2021

To help you identify new companies, we're sharing ones we've found recently with notable FDA 510(k) clearances, funding, new products and studies. Here, we highlight entities with products for robotics/digital, spine and orthobiologic applications.   ...

Read more »

Researchers Create Artificial Bones with Hot Nano-Chisel

by Annie Zaleski | Mar 2021

Researchers announced they’ve developed a way to produce artificial bone tissue that mimics the biological structures and complexities of naturally occurring bone tissue.   ... Read more »

LimaCorporate and HSS Open First Provider-based Design and 3D Printing Center for Complex Joint Reconstruction

by Julie A. Vetalice | Mar 2021

HSS patients will be scanned onsite, and their custom implant will be designed and fabricated in the onsite center using LimaCorporate's Trabecular Titanium technology. This design and manufacturing service will also be accessible to patients from other U.S. hospitals.   ... Read more »

The Unknowns of Surgical Drilling

by OMIC | Mar 2021

A study by The Oregon Manufacturing Innovation Center, Research & Development team finds change to design and materials can extend the lifespan of orthopedic drills.... Read more »

ACL Advancements Build on Body’s Biology

by Heather Tunstall | Mar 2021

Sports medicine companies focus new ACL repair techniques on native tissue and biomimetic solutions.   ... Read more »

Researchers Develop New Biomaterial for Cartilage Regeneration

by Patrick McGuire | Feb 2021

CartiScaff largely resembles original cartilage in terms of structure and composition, and serves as a component of the regenerative tissue, thereby assisting the process or tissue formation.   ... Read more »

Researchers Pioneer 3D-Printed Bone Structures with Living Cells

by Patrick McGuire | Feb 2021

The technique could prove to be a solution for autologous grafts and bone reconstruction.   ... Read more »

Miach Orthopaedics Reimagines ACL Repair with BEAR Implant

by Heather Tunstall | Feb 2021

The BEAR Implant is the first medical technology to clinically demonstrate that it can restore the native ACL without having to replace or reconstruct it.   ... Read more »


How Product Development Teams are Coping with COVID

by Patrick McGuire | Feb 2021

Orthopedic leaders share how their teams have stayed aligned and maintained productivity throughout the pandemic.   ... Read more »

New AR Glasses Used in Holographically-Navigated Spine Surgery

by Patrick McGuire | Jan 2021

A university startup teamed with Microsoft to build augmented reality technology for spinal surgery. The first procedure launched a randomized clinical study.    ... Read more »

Trauma Technologies Emerge to Meet the Needs of Patient Anatomy

by Patrick McGuire | Nov 2020

 A burgeoning set of small orthopedic implant companies is developing devices designed to anticipate and suit individual patients’ unique anatomy.... Read more »

3 DF(x) Elements to Follow for New Product Development

by Kathie Taylor | Nov 2020

A modern design for manufacturability approach forces orthopedic device companies to develop products aligned with customer needs and business needs.... Read more »

Essential Steps to Proactively Improve Your Product Development Process

by Kathie Taylor | Nov 2020

In a perfect world, product development goes smoothly. However, we don’t live in a perfect world. Our imperfection is why a focus on process improvement to enhance our work product is worth R&D teams pursuing.... Read more »

Cerapedics’ Deliberate, Thorough Approach was Crucial for i-FACTOR’s Success

by Patrick McGuire | Nov 2020

Cerapedics is one of only two companies with FDA Class III bone graft technology approved for the spine market. The company's leadership team shares the long road to commercialization. ... Read more »

AI is the Next Great Advancement in Orthopedic Technology

by BONEZONE | Oct 2020

How is AI shaping orthopedic technology? While the timeline for broader acceptance of AI in orthopedics is uncertain, its vast scope and power is already making an indelible impact.   ... Read more »

Innovative Technologies Shake Up the Orthopedic Space

by Heather Tunstall | Sep 2020

Dozens of startups are poised to shake up the orthopedic space in the near-term and beyond. We start by examining five companies from different segments of orthopedics that recently reached the market or plan to by 2022.... Read more »

Considerations for Your Device’s Manual and Mechanical Cleaning Validations

by Gary J. Socola | Sep 2020

Proper cleaning protocols for reusable medical devices have become a major focus in light of the recent superbug outbreaks associated with improperly cleaned duodenoscopes. Orthopedic OEMs need to validate either a manual or mechanical cleaning process (savvy manufacturers do both) when seeking... 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 »

4 Human Factors Practices that Lead to Successful FDA Submission

by Kathie Taylor | Sep 2020

Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not new to you, they serve as a refresher for what FDA is closely considering with your submission.... Read more »

Researchers Developing a Plastic Biomaterial for Use in Orthopedics

by Patrick McGuire | Sep 2020

“This is a new class of biocompatible plastic that is as strong as nylons but is much easier to shape and manipulate due to its unique structural design, which is only accessible using our synthetic approach," said University of Birmingham's Josh Worch, Ph.D.... Read more »

Study Finds Additive Manufacturing Success with Nitinol

by Gaurav Lalwani, Ph.D. | Aug 2020

Carpenter Additive carried out a study to create a systematic framework to optimize additive manufacturing for Nitinol. The study focused on multiple factors, including stringent control of Nitinol chemistry.... Read more »

3 Questions on 3D Printing

by Patrick McGuire | Aug 2020

As 3D printing of orthopedic implants and instruments evolves, so too will the technology used to design and manufacture products. We reached out to experts to discuss design, software, materials and post-processing.... Read more »

How to Create a Product Development Roadmap

by Kathie Taylor | Jul 2020

Product portfolio roadmapping is like taking a trip. Companies must decide where they're going and how they're going to get there in order to be successful.... Read more »

Why You Should Engage Suppliers in DFMEAs

by BONEZONE | Jul 2020

This practice not only benefits the OEM, but the supplier as well. By partnering in the early stages of development, OEMs can launch a product at a lower risk of encountering manufacturing challenges once released.... Read more »

OrthoDX Creates Prototype for Joint Replacement Implantable Sensor

by Patrick McGuire | Jul 2020

OrthoDX's intramedullary sensor is 10mm in diameter and detects micronic shifts in orthopedic devices. The company’s next steps are finding a material to encapsulate the sensor and ensuring that they can measure motion on all planes.... Read more »

Orteq Promotes Joint Preservation with Meniscus Implant

by Kathie Taylor | Jul 2020

Orteq’s ACTIfit received FDA Breakthrough Device Designation, an important milestone toward entering the U.S. knee market. ... Read more »

Exactech Transitions Equinoxe Stemless Shoulder to 3D Laser Printing Process

by Julie A. Vetalice | Jul 2020

The bone-conserving anatomic total shoulder is now being manufactured using direct metal printing with high precision lasers to create its porous bone cage.   ... Read more »

OsteoFab PEKK: Desirable Material Properties and 3D Printing Combine to Enhance Orthopedic Solutions

by Andrus Maandi | Jul 2020

Numerous studies on material and implant structure have detailed the benefits of OsteoFab PEKK – a formulation of polyetherketoneketone – that is 3D-printed for orthopedic applications.... Read more »

New 3D-Printed Liquid Crystal Elastomer Developed for Spine

by Heather Tunstall | Jul 2020

A new material could prove to be an improvement on current treatment techniques for spinal fusion and potential disc replacement. The research team created a 3D-printed semi-crystalline liquid crystal elastomer spinal fusion cage that more closely mimics the properties of biological tissue. ... Read more »

Smith+Nephew Launches INTELLIO Connected Tower for Sports Medicine

by Julie A. Vetalice | Jun 2020

The new INTELLIO Connected Tower Solution wirelessly connects and remotely controls multiple Sports Medicine systems from outside the sterile field.   ... Read more »

Spinal Elements Introduces the MIS Ultra Platform of Products and Procedures

by Julie A. Vetalice | Jun 2020

Spinal Elements introduced its MIS Ultra platform of products and procedures designed to minimize the unintended consequences of spine surgery.   ... Read more »

Successful Design and Development Requires Early Collaboration

by Heather Tunstall | Jun 2020

In this competitive environment where speed to market is vital, the design and prototyping phase of any orthopedic project carries more importance than ever before. Companies that can collaboratively work with suppliers from the onset and communicate throughout the project will have a better chance ... Read more »

DiFusion Brings First Immuno-stealth Polymer to Orthopedic Market

by Kathie Taylor | Jun 2020

PEEK and titanium dominate the spinal fusion market—two materials with roots in the aerospace industry. DiFusion received FDA 510(k) clearance to market a spinal interbody made of ZFUZE, a new polymer engineered specifically for orthopedics.... Read more »

Keys to an Effective Additive Manufacturing Quality System

by Kathie Taylor | Jun 2020

FDA and Stryker joined an additive manufacturing panel to discuss the importance of quality systems and industry and regulator collaboration.... Read more »

What Does the Next Generation of Total Ankles Need?

by Kathie Taylor | May 2020

Preoperative planning, surgical instrumentation and bony ingrowth are advancements that surgeon Alan Davis, M.D., says are a must for future total ankles.... Read more »

Embody Raises Funds for Soft Tissue Repair Technology

by Julie A. Vetalice | May 2020

Funds will support commercial launch and postmarket clinical studies of the Tapestry system to treat serious tendon and ligament injuries.   ... Read more »

3 Design and Manufacture Considerations for Outsourcing

by BONEZONE | May 2020

Create a list of questions and considerations for your supplier partner. What are their capabilities? What is their expertise? What best practices do they follow?... Read more »

Integrated Endoscopy Solves Arthroscope Design Challenges with NUVIS

by Heather Tunstall | Apr 2020

The NUVIS system reduces wires and equipment with a single-use, HD arthroscope.... Read more »

How to Ensure a Well-Established Problem Definition

by Kathie Taylor | Apr 2020

Empathic design pushes product development teams to follow the user journey to gain a sense of the true problem they’re trying to fix.... Read more »

How to Implement a Solid Approach to Materials Intelligence

Understanding how materials move through each aspect of the product development process can significantly shorten time-to-market, reduce the risk of compliance issues, fine-tune manufacturing processes and improve overall device quality.... Read more »

Enabling Technology is Here to Stay

by Mike Evers | Mar 2020

Commentary from executives and spending patterns of the largest orthopedic companies have affirmed that robotics will continue.... 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 »

3D-Painted Hyperelastic Bone Brings New Material to Orthopedics

by Heather Tunstall | Mar 2020

Dimension Inx is bringing 3D-painted orthopedic devices to market to aid tissue repair and bone regeneration. The materials offer alternatives to titanium and polymers.... Read more »

Fusion Robotics Goes Small with 4-Pound Robot

by BONEZONE | Mar 2020

Fusion Robotics seeks to introduce the world’s first portable spinal robotic navigation offering. It can easily fit within a suitcase for simple travel.   ... Read more »

Suppliers Continue Polymer Advancements

by BONEZONE | Mar 2020

Last year was a big one for polymer supplier news. Here’s a wrap up of recent strategic announcements.   ... Read more »

Startups to Drive Polymer Innovation in the New Decade

by Kathie Taylor | Mar 2020

While the orthopedic device industry has changed its tune on metals vs. polymers over the last 20 years, the push for material innovation has remained. Entering a new decade, orthopedics is experiencing another wave of polymer innovation that provides greater design freedom and compatibility with th... Read more »

NGMedical's First Implantations with MOVE-C Cervical Disc

by Julie A. Vetalice | Feb 2020

MOVE-C combines the features of a second-generation disc prosthesis with the implantation technique of a cervical cage. The device offers physiological motion in all six planes, including axial damping with progressive resistance to motion.   ... Read more »

ASTM, America Makes Prioritize Additive Manufacturing Data Management

by Heather Tunstall | Feb 2020

 ASTM and America Makes are among additive manufacturing organizations creating a data collection and utilization roadmap to bolster the additive process.... Read more »

Design Planning with Your Manufacturer May Save Time and Cost

by BONEZONE | Jan 2020

Device companies should encourage their engineers to work with manufacturers even during the concept phase of design. This relationship allows teams to identify the design inputs that affect manufacturing and inspection methods and costs, and together ensure the best design for the product.... Read more »

How to Control Project Scope Creep

by Kathie Taylor | Jan 2020

Directional change and scope creep are inevitable in product development. However, their effects can be minimized through a systematic approach.... Read more »

9 Rules for Orthopedic Product Development

by Dale Tempco | Jan 2020

Rule #1 for successful product development is to tie design outputs to user needs. Dale Tempco shares how this step and eight others helped him decrease product development setbacks throughout his career. ... Read more »

Muvr Labs Brings Wearable Technology to Joint Replacement Recovery

by Heather Tunstall | Jan 2020

Startup Muvr Labs seeks to deliver a recovery solution that includes wearable devices, measuring and monitoring tools and greater interaction among the surgeon, physical therapist and patient.... Read more »

ASTM Launches Personnel Certificate in Additive Manufacturing

by Julie A. Vetalice | Jan 2020

Specific modules will address terminology, AM process overview, design and simulation, post-processing, mechanical testing, etc.   ... Read more »

DePuy Synthes, Zebra Medical to Partner on AI in Orthopedics

by Julie A. Vetalice | Jan 2020

Zebra Medical's algorithm-based artificial intelligence technology will be part of DePuy Synthes’ VELYS Digital Surgery solutions for pre-operative, operative and post-operative care of patients undergoing joint, trauma and spine procedures.   ... Read more »

6 Orthobiologic Companies Move Clinical Trials Forward

by BONEZONE | Dec 2019

Multiple orthobiologic companies have engaged in clinical trials in 2019, seeking to demonstrate the efficacy of their cell-based products. We've recapped announcements from six of those companies.   ... Read more »

Smith+Nephew Announces First JOURNEY II Unicompartmental Knee Procedures

by Julie A. Vetalice | Dec 2019

The JOURNEY II Uni Knee is designed to bring the natural feel of JOURNEY II to partial knee arthroplasty patients and help drive value in healthcare systems.   ... Read more »

ulrich medical USA Launches Momentum Posterior Spinal Fixation

by Julie A. Vetalice | Dec 2019

Momentum is compatible with the company's neon3 Universal OCT Spinal Stabilization System, which launched in 2012.   ... Read more »

Executive Interview: Carmell Therapeutics on its Controlled Degradable Biologic

by Heather Tunstall | Dec 2019

Carmell Therapeutics' proprietary process binds and cross-links regenerative factors in lyophilized platelet-enriched plasma into solid and semi-solid plasma-based materials to accelerate healing in bone, tendon and wound care. The company is waiting on IND clearance before starting its pivotal tria... Read more »

Strategic Initiatives: CrossRoads Extremity Builds Portfolio, Mathys and BREHM to Co-Market Products

by Julie A. Vetalice | Dec 2019

A growing extremities company grows even more, and two well-established joint replacement players collaborate globally on components for hip replacement.   ... Read more »

4 New Technologies in Spine, Joint Replacement, Trauma, Sports Medicine

by Julie A. Vetalice | Dec 2019

Small and mid-sized orthopedic companies bolstered their portfolios at year-end with products to help grow revenue in the coming year.   ... Read more »

Orthopedic OEMs Seek to Outsource More Design Work

by Heather Tunstall | Dec 2019

Suppliers and design firms are expanding their capabilities in anticipation of orthopedic device manufacturers outsourcing more product development work. We spoke with four companies about what type of product development work they're increasingly being asked to do and why they think outsourcing of ... Read more »

Design for Manufacturing: An Engineer’s Guide to Machine Tools

by Heather Tunstall | Nov 2019

This guide provides basic knowledge of how the drill press, mill, lathe, EDM and cutting tools operate, as well as strengths and limitations of each technology to help improve engineers’ designs.... Read more »

Smith+Nephew Launches OR30 Dual Mobility Hip

by Julie A. Vetalice | Nov 2019

OXINIUM Technology is the first advanced bearing material available to support modular dual mobility throughout the entire offering.   ... Read more »

Pristine Surgical Enters Sports Med Market with Single-Use Surgical Imaging System

by Heather Tunstall | Nov 2019

Pristine Surgical is expected to launch to market an arthroscope that includes a single-use digital imaging platform in the first half of 2020. The company's technology includes inventory management capabilities, patient engagement tools, pre- and post-op communications and training compon... Read more »

4 Key Elements of Design Controls

by Heather Tunstall | Nov 2019

Design controls require an integrated and complex process that includes inputs and outputs, reviews, verification and validation, as well as design transfer. We provide a primer on four important elements during design development.... Read more »

WishBone Medical Enters Global Distribution Agreement with Optimal

by BONEZONE | Oct 2019

WishBone Medical signed an agreement with logistics company Optimal, supporting global distribution of single-use, sterile packed orthopedic implants for pediatric applications.   ... Read more »

DePuy Synthes to Promote TINAVI Robotic Solutions in China

by BONEZONE | Oct 2019

Together, the companies will jointly promote the rapid development of digital surgery and technological medical innovation, providing insights for the Chinese medical industry through local collaboration and optimizing patient experience.  ... Read more »

THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application

by Julie A. Vetalice | Oct 2019

Previously available in Asia Pacific and European markets, the TSolution One system is now cleared for use in the U.S. in total knee replacement.  ... Read more »

3 Stem Cell Product Updates: Knee OA Clinical Trials, Degenerative Disc Treatment Launch

by Julie A. Vetalice | Oct 2019

Clinical trials are underway in the U.S. and China for use of stem cell therapies in the treatment of knee osteoarthritis. U.S. product commercialization is commencing for a regenerative stem cell procedure to treat chronic lower back pain.   ... Read more »

Zimmer Biomet, CarboFix and Aegis Spine Make Post-NASS Announcements

by Julie A. Vetalice | Oct 2019

Zimmer Biomet introduced its first porous titanium implants to be additively manufactured. Aegis added expandable cages to its portfolio, and CarboFix launched another device made from carbon fiber.    ... Read more »

ADAM to Launch Human Trials of 3D-Printed Bone

by Julie A. Vetalice | Oct 2019

The startup plans to complete pre-clinical trials within the month and commence first human trials by the end of 2019. The project seeks to reduce the cost for synthetic bone production by half.   ... Read more »

NASS Review: Spinal Robotics, Enabling Technologies, 3D Printing and Biologics

by Mike Evers | Oct 2019

Enabling technologies were the story of the North American Spine Society 2019 Annual Meeting, with the top spine players prominently featuring an array of robotic-assisted surgery ecosystems.   ... Read more »

Stryker, SeaSpine and Innovasis Ink New Licensing Deals

by Julie A. Vetalice | Oct 2019

Conformis will supply patient specific instrumentation to Stryker, Innovasis signed a deal to access porous HA PEEK and SeaSpine is entering the 3D-printed interbody space.   ... Read more »

Brainlab, Epica, Onkos Surgical Launch New Surgical Enabling Tools

by Julie A. Vetalice | Oct 2019

Brainlab is back with more robotic technology, Epica’s mobile CT imaging is cleared for human use applications and Onkos enhances joint sparing tumor procedures.   ... Read more »

How Do EDM and Cutting Tools Work?

by Deborah Munro | Oct 2019

Electric discharge machining (EDM), laser cutters and plasma cutters offer you alternative ways to cut metal parts at different speeds. We share what you need to know about these machine tools.... Read more »

Sports Medicine Product Updates: CoNextions Medical and Fuse Medical

by Julie A. Vetalice | Sep 2019

In keeping an eye on lesser-known companies, we noticed two up-and-comers to share. These small startups are increasingly appearing in the news.   ... Read more »

Knee Replacement Launches: ATTUNE Cementless, Persona Revision and Sterizo Total Knee

by Julie A. Vetalice | Sep 2019

Knee segment leaders DePuy Synthes (#3) and Zimmer Biomet (#1) enhanced their offerings and noted that their new knee systems combined with their robotic-assisted systems will boost revenue. Smaller player Fuse Medical launched its next-generation total knee platform and announced further product la... Read more »

Trauma: A Regulatory and Product Launch Recap

by Julie A. Vetalice | Sep 2019

The number of companies in the trauma space may surprise you since the largest orthopedic players—DePuy Synthes, Stryker, Zimmer Biomet and Smith & Nephew—seem to dominate the news. In anticipation of the OTA Annual Meeting this week, and in response to your requests for continued coverage o... Read more »

X-BOLT Introduces New Hip Fracture Concept

by Heather Tunstall | 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 »

Vallum’s Nanotechnology Addresses PEEK’s Hydrophobic and Bioinert Shortcomings

by Heather Tunstall | Sep 2019

Numerous spine companies manipulate PEEK to promote osseointegration with interbody devices, but Vallum believes they are the only one addressing the hydrophobic and bioinert drawbacks of the polymer material.   ... Read more »

HSS Launches First Study Testing Cell Therapy for Rotator Cuff Surgery

by BONEZONE | Sep 2019

The Hospital for Special Surgery has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery.   ... Read more »

Computational Modeling Gets Boost from ASME Standard, FDA Science Priority

by Kim Snell | Sep 2019

A new standard and FDA’s regulatory science priorities focus on computational modeling & simulation, which provide indication that orthopedic device professionals should look to understand and leverage the tool's benefits.... Read more »

cultivate(MD) Invests in Genesis Software Solutions for Orthopedics

by Julie A. Vetalice | Sep 2019

The cultivate(MD) Capital Fund II of Genesis Innovation Group made an investment in Genesis Software Innovations (GSI), developer of software solutions that will initially focus on the orthopedic space. ... Read more »

Loci Orthopaedics Gains Funding for Thumb Base Joint Implant

by Julie A. Vetalice | Aug 2019

The company was awarded a €2.5 million grant, received a U.S. patent and entered into a new technology license agreement.   ... Read more »

Stryker to Acquire Sterilization Specialist TSO3

by Julie A. Vetalice | Aug 2019

The STERIZONE VP4 Sterilizer is reportedly the most cost-effective low-temperature sterilizer on the market today, per instrument sterilized, compared to hydrogen peroxide low-temp systems.   ... Read more »

HAPPE Spine to Develop Strong, Porous, Bioactive Spinal Fusion Implants

by Heather Tunstall | Aug 2019

Startup HAPPE Spine is rethinking the way that PEEK and hydroxyapatite are manufactured together to make an interbody that maintains load-bearing strength and facilitates osteointegration and radiolucency. ... Read more »

Xenco Medical Takes a Single-Use, Pre-Loaded Approach to Spinal Implants

by Heather Tunstall | Aug 2019

In an effort to curb infections and sterile processing inefficiencies, Xeno Medical has developed a new material and rethought manufacturing and packaging for its spinal implants.... 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 Testing Companies Advise How to Handle Evolving Requirements

by Kim Snell | Aug 2019

Orthopedic device companies should proactively ask FDA and other regulatory bodies about important testing requirements and changes to regulations and standards.... Read more »

The Lathe: Engineers Take Note of Dimensions When Designing Components

by Deborah Munro | Jul 2019

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

How Good Project Management Can Reduce Production Delays

by Hal Conick | Jun 2019

Good project managers know how to effectively outline a process and assess risk in order to stay on time and budget.... Read more »

Onkos Surgical’s Personalized Approach to Treating Musculoskeletal Cancers

by Heather Tunstall | Jun 2019

Onkos Surgical targets underserved oncology surgical market with an expanding portfolio of implants and technology.... Read more »

Infographic: Robots in Orthopedics

by BONEZONE | Jun 2019

Robotics is a priority for the top players in orthopedics. Our infographic highlights the ten robots presently on the market, including launch dates and markets served.... Read more »

Engineers: Don’t Let Increased Regulatory Requirements Slow Your Design Process

by BONEZONE | Jun 2019

Adhering to best practices allows engineers to work effectively within parameters of the regulations and plan projects in a way that makes regulations more manageable.... Read more »

Embody Develops Biointegrative Collagen-based Implant for Soft Tissue Injuries

by Heather Tunstall | Jun 2019

Embody utilizes a novel additive manufacturing process to develop its Tapestry biomaterial. The company anticipates commercial launch in 2020 for its Achilles and rotator cuff scaffolds and a 2022 timeline for ACL repair.... Read more »

Unlock DFM Benefits: A Guide for Product Development Leadership

by Dale Tempco | May 2019

Device companies focus on DFM is shortsighted. DF(x) allows companies to account for designing for manufacturability, as well as design for inspection, assembly, low cost, manufacturing efficiency, business needs, manufacturing throughput, packaging/transportation, etc.... 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 »

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

by Deborah Munro | 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 »

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 »

UDI Laser Marking Improved with Vision Technology

by Faycal Benayad-Cherif | 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 »

Orthofix M6-C Artificial Cervical Disc Study: Full 2-Year Data

by Julie A. Vetalice | Apr 2019

The M6-C is a next-generation artificial cervical disc developed to replace an intervertebral disc damaged by degeneration. Its physiologic one-piece design features an artificial nucleus and annulus that mimic the biomechanical motion of a natural disc, to include axial compression or shock ab... Read more »

Smart Medical Devices Launching SMARTdrill 6.0

by Julie A. Vetalice | Mar 2019

The device is intended to curtail drill and screw plunge, and to accurately measures depth, torque and energy in real-time.   ... Read more »

Atlas Spine Launches HiJak AC Expandable Interbody

by Julie A. Vetalice | Mar 2019

HiJak addresses complex cervical conditions, and can adjust both height and lordosis to restore balanced sagittal alignment.    ... Read more »

Amplify Surgical's dualX Dual Expanding Interbody Fusion Used in First Cases

by Julie A. Vetalice | Mar 2019

The dualX device expands in both width and height providing a stable foundation for spinal fusion.   ... Read more »

Aesculap Biologics Announces NOVOCART 3D Trial Enrollment Milestone

by Julie A. Vetalice | Mar 2019

Approximately 117 study participants have been treated, bringing enrollment to 50% completion.   ... 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 »

Antimicrobial Coatings Closer to Commercialization

by BONEZONE | Mar 2019

Public-company announcements, as well as conversations we’ve had with members of industry, indicate that manufacturers continue to push toward commercializing coatings that prevent surgical infections and that productive conversations are taking place with regulators.... 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 »

Device Design Should Favor Scientific Approaches Over Check-the-Box Mentality

by BONEZONE | Mar 2019

When it comes to solving complex problems, such as the orthopedic device design control process, the incompetency and laziness from always “checking a box” can lead to disorder and a marked lack of productivity.... Read more »

Orthopedic Infection Prevention: Why One Researcher is Focused on Packaging

by BONEZONE | Mar 2019

As the orthopedic industry places greater emphasis on surgical site infection, one spine company touts a system that impedes all pedicle screw contact.... Read more »

Knee Innovation Focused on Materials, Design and Computer-Assisted Improvements

Innovation in knee replacement devices has been driven by materials, designs and computer-aided and robotic-systems. These three trends will continue to propel future knee advancements.... Read more »

Drill Press Review: These Basic Principles Can Benefit Design for Manufacturability

by Deborah Munro | Feb 2019

The main purpose of a drill press is to machine holes. Orthopedic engineers should keep the following rules in mind to improve their drawings and make the machinists’ job easier.... Read more »

Insight Medical Completes Cadaver Lab with ARVIS Augmented Reality Visualization

by Julie A. Vetalice | Feb 2019

The company plans a 2019 launch of AR navigation for spinal fusion, joint reconstruction and the repair of anterior cruciate ligaments.   ... Read more »

DePuy Synthes Plans Additive Manufacturing R&D Expansion at Ireland Facility

by BONEZONE | Feb 2019

DePuy Synthes’ investment includes a 3D-printing Development and Launch Center and implementation of the Johnson & Johnson 3D Bioprinting Laboratory. Projects will focus on advancing materials in additive manufacturing, coatings and surface treatments.... Read more »

Aesculap Implant Systems PlasmaporeXP Surface Enhancement Study

by Julie A. Vetalice | Feb 2019

This data reinforces years of clinical experience with the Plasmapore technology, beginning with the surface-enhanced BiContact hip implant over 30 years ago.... Read more »

Osso VR Gains Funding in Support of Virtual Reality Surgical Training

by Julie A. Vetalice | Feb 2019

The virtual reality-based platform is using Small Business Innovation Research Program support to add automation to its surgical assessment tool.... Read more »

GEO CART Designed to Address Operating Room, Supply Chain Efficiency

by Rob Meyer | Nov 2018

Gramercy Extremity Orthopedics’ GEO CART® is a mobile storage and point-of-sale system that houses 2,000+ sterile-packed instruments and implants that are tracked and managed with RFID technology. It aims to address issues such as O.R. product availability, sterile processing risks and device bil... Read more »

OEMs Continue Focus on Reducing Instruments in Operating Rooms

by Rob Meyer | 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 »

11 Arthroscopy/Soft Tissue Repair Companies Worth Watching

by Julie A. Vetalice | Oct 2018

We looked at funding, patent and trial/study announcements from January 2017 to June 2018 to see whose initiatives are making waves; many of these companies offer technologies that could make them acquisition or collaboration targets for large OEMs.... Read more »

AIRO Focuses on Robotic, Artificial Intelligence Application for Joint Reconstruction

by BONEZONE | Sep 2018

Brett Robertson, Managing Director for the Australian Institute of Robotic Orthopaedics, explains how AIRO is leveraging decades of orthopaedic expertise to deliver a platform technology that unites lasers, robot-assisted motion, computational modeling, AI, digital sensing and real-time responses.... Read more »

ACL Reconstruction Startup Secures Funding to Support IDE Clinical Trial

by Rob Meyer | Sep 2018

Company founder Martha Murray, M.D., pioneered Bridge-Enhanced® ACL Repair (BEAR) technology, a proprietary bio-engineered sponge used as a bridging scaffold to stimulate healing of a torn ACL. MIACH Orthopaedics has initiated an IDE to support future FDA Premarket Approval.... Read more »

Additive Manufacturing: How One OEM Approaches Prototyping

by Asher Breverman | Sep 2018

An additive manufacturing expert from Osseus Fusion Systems shares how AM allows a small spine company to bring prototyping in-house for time and cost efficiencies while also maintaining surgeon engagement. ... Read more »

First Two United States Patients Receive CartiHeal’s Agili-C Implants

The Israeli startup develops implants to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints; to date, 80 patients in Europe and Israel have been treated in the pivotal Agili-C IDE study.... Read more »

Ortho Development Announces First Surgery Using Balanced Knee System in China

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 »

Cerapedics Enrolls Patients in P-15L Peptide-Enhanced Bone Graft IDE Trial

P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation. Cerapedics has enrolled the first of 364 patients in this IDE clinical trial.... Read more »

206 Ortho Secures Patent for Technology That Incorporates Biodegradable Material

by Rob Meyer | Jul 2018

The company has developed a bio-inspired non-metallic composite and implants made with a high-strength, biodegradable material intended to repair load-bearing bone and resorb completely. 206 Ortho is pursuing additional funding and potential commercialization partners.... Read more »

Final Patient Treated in NUsurface Artificial Meniscus Trials

by Julie A. Vetalice | Jul 2018

Active Implants is pursuing an FDA De Novo 510(k) clearance for the device. If cleared, NUsurface would be the first “artificial meniscus.” ... Read more »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by Rob Meyer | Jun 2018

Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images.... 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 »

Robotics in Orthopaedic Surgery: Answers to Three Questions

by Rob Meyer | May 2018

We examine the players and products, address data and adoption, and look at who is driving the push toward the technology.... Read more »

Study: Indentations on Artificial Femoral Heads Could Improve Implant Longevity

by Rob Meyer | 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 »

Ceramics Expo 2018: Three Takeaways for Orthopaedic Engineers

by Rob Meyer | May 2018

Topics of interest included a deep dive into the role of advanced data analytics in manufacturing and the future of ceramics in the spine space.... Read more »

Successful Medical Device Design Transfers Hinge on Advance Planning

by David Finch | 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 Rob Meyer | 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 »

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

by Rob Meyer | Apr 2018

Exactech’s FDA-cleared Equinoxe is competition for Wright Medical and Zimmer Biomet’s offerings. The three are the only FDA-cleared stemless shoulders in the U.S.... Read more »

Scientists Successfully Test New Titanium Plate for Bone Tissue Repair

by Rob Meyer | Apr 2018

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

Globus Medical Making Sizable Push Into Trauma Market

by Rob Meyer | Mar 2018

The company debuted its suite of FDA-510(k)-cleared trauma products in four families at the 2018 American Academy of Orthopaedic Surgeons annual meeting.... Read more »

Precision, Accuracy Among Swiss Machining Benefits

by Rob Meyer | Feb 2018

"Because of the technology," one supplier says, "you’re able to drop off parts to the customer complete and don’t have to go to secondary operations, which costs money and time. Swiss-type screw machines are so complete, in terms of capabilities."... 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 »

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

by Deborah Munro | 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 »

Episurf Medical to Launch Custom Ankle Implants Using Episealer® Technology

by BONEZONE | Feb 2018

The Stockholm, Sweden-based company is preparing a 2Q18 launch of patient-specific Episealer® implants to treat osteochondral lesions of the talus in the ankle. ... Read more »

Articulus Bio Gains Funding, Focusing on Total Ankle Replacement

by BONEZONE | Jan 2018

The company is addressing the issue of wear debris and seeks capital to collect data on sub-assembly components of its Tendonoid™ Web Joint technology.... 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 »

Augmedics Bringing X-Ray Vision to Surgery with X-VISION Visualization System

by Rob Meyer | Jan 2018

With its first application in minimally invasive spine procedures, X-VISION technology is designed to save time during surgery, reduce radiation exposure and reduce the number of repeat operations and hospitalizations.... 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 »

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 »

DePuy Synthes Introduces PUREVUE HD Visualization

by BONEZONE | Dec 2017

PUREVUE comprises a light source, image processer and image management in one compact footprint, and can be used for a variety of minimally invasive surgical applications.... Read more »

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »

Learn to Incorporate Sensors Into Your Next Design Idea

by Deborah Munro | Dec 2017

Microelectromechanical 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 Rob Meyer | 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 »

Three Companies Expand Patient Engagement Offerings and Digital Tools

by Julie A. Vetalice | Nov 2017

These tools are being launched by companies that seek to remain competitive in the market as they help hospitals and surgeons improve patient outcomes and control spend. ... 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 Julie A. Vetalice | 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 »

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 »

Vivorte Launches New Bone Graft Products

by Julie A. Vetalice | 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 Denise Dion | Oct 2017

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

Flower Orthopedics Expands Ready-For-Surgery Extremity Line

by Julie A. Vetalice | Oct 2017

Flower Orthopedics launched three new products: instruments in the Flower Efficiency (E-Kit™) Advanced system.... 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 »

Zimmer Biomet Launches Persona Partial Knee

by BONEZONE | Sep 2017

Zimmer Biomet commenced global launch of the Persona® Partial Knee at the end of August. This is the first significant jointly-developed new product for the combined ZBH entity.... Read more »

Lima Corporate Reaches Milestone for SMR Modular Shoulder

by BONEZONE | Sep 2017

Lima Corporate reaches 100,000 implant milestone for SMR shoulder system since launch in 2002.... Read more »

Bone Biologics Targets Spine Fusion with UCLA License Agreement

by BONEZONE | Sep 2017

Bone Biologics entered into an exclusive license agreement with UCLA for global application of NELL-1/DBX® protein in the treatment of osteoporosis and trauma through a technology transfer.... Read more »

Medtronic Assumes Exclusive Commercial Rights for Mazor X

by Julie A. Vetalice | Sep 2017

Medtronic entered Phase II of its strategic partnership with Mazor Robotics, granting Medtronic exclusive global distribution of the Mazor X surgical robotic assistance platform. The partnership affords Medtronic the lead in robotics amongst the largest spine players.... 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 »

MicroPort Orthopedics Launches Procotyl Prime Acetabular Cup

by BONEZONE | Sep 2017

MicroPort Orthopedics launched the Procotyl Prime acetabular cup, the next step in the evolution of the Dynasty Acetabular Cup System. The device received FDA 510(k) clearance at the end of 2Q17.  ... Read more »

Globus Medical Receives Clearance for Excelsius GPS

by BONEZONE | Aug 2017

Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and orthopaedic surgery.... Read more »

DePuy Synthes Launches Distal Radius Sterile Kit

by BONEZONE | Aug 2017

The kit is a response to surgeons' needs for a simplified system that enhances OR efficiency and minimizes procedure delay, while appealing to the hospital's requirement to reduce sterilization costs.   ... Read more »

Robotics, 3D Printing Gain Larger Adoption with Globus Medical, K2M Acquisitions

by Julie A. Vetalice | Aug 2017

In early August, both Globus Medical and K2M announced acquisitions that complement current products and position them for future growth.... Read more »

3D-Printed Model Reduces Surgery Time, Cost

by BONEZONE | Aug 2017

A new study has shown potential for a cost savings of $2,700 when using a 3-D printed model for surgical planning. The savings are derived from a 25% reduction in surgery time when the 3-D printed models were used. ... Read more »

Entrepreneurial Engineering: Start with the Problem

by Deborah Munro | Aug 2017

Entrepreneurial engineers look beyond the obvious to see the bigger picture. So often, it’s less valuable to take problems at face value and solve them as assigned without looking at the matter more broadly. Ask yourself some key questions to gather ideas, make them tangible and lend detail to you... Read more »

Design Validation: More than Just User Testing

by BONEZONE | Aug 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, corrects a common misconception.... Read more »

Spine Fusion Stimulated by Sugar-Coated Nanomaterial

by BONEZONE | Jul 2017

Northwestern University scientists found that nanomaterial coated in sugar molecules can stimulate bone regeneration in spinal fusion.... Read more »

Clinical Trial to Evaluate Stem Cell Treatment of Massive Knee Cartilage Injury

by BONEZONE | Jul 2017

Andrews Institute for Orthopaedics & Sports Medicine and the Andrews Research & Education Foundation are facilitating a randomized, multi-center Phase II U.S. FDA-observed clinical trial evaluating use of a patient's own stem cells to regenerate knee cartilage.... 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 »

UNM Pursuing 3D Printing of Tissue for Extremity Reconstruction

by BONEZONE | Jun 2017

With the support of a $20,000 grant from The American Foundation for Surgery of the Hand, a research team at UNM seeks to make 3Dprinted bone/ligament hybrid tissue for use in hand and wrist procedures.... Read more »

Proving Your New Design is Production Equivalent

by Denise Dion | Jun 2017

Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh in on how to determine your product is production equivalent.... Read more »

Pareto Analysis: Tools for New Product Testing

by John McCloy | 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 »

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 »

Design Intent: Do I Need to Perform Verification and Validation?

by Denise Dion | Apr 2017

If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs or outputs, do you have to formally perform verification and validation? Our experts respond.... Read more »

Reducing the 1% Failure Rate through Testing & Analysis

by John McCloy | Mar 2017

John McCloy offers solutions to reducing the 1% failure rate of medical implants through testing & analysis... Read more »

Silver Ions Found Effective in Fighting Infections while Forming Bone

by BONEZONE | Mar 2017

An international team of researchers developed a scaffold that could prevent or kill MRSA and support bone tissue formation.... 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 »

2016: The Year in Products and Services

by BONEZONE | Dec 2016

What are you working on for 2017? How do your daily tasks align with overall growth objectives? We look forward to sharing your successes in these pages next year. Until then, let’s reflect on what fueled momentum this year.... Read more »

Class II Design Problem Solved with Simulation

by Eric Lintula | Oct 2016

Many articles generalize design controls, but few provide direct application. This article offers a broad overview for engineers and their managers to highlight the milestones of a design process from design request to purchase order, using Finite Element Analysis.... Read more »

Spinal Fusion Device in Development Eliminates Bone Graft and Pedicle Screws

by Hannah Corcoran | Oct 2016

Researchers at The University of New South Wales developed a fusion device designed to stabilize the spine without bone graft or pedicle screws in single-level posterolateral fusion.... 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 »

The Advantage of Adverse Event Wear Testing

by Gemma Budd | Aug 2016

Advances in the development of prosthetic joints and materials have led to a need for more effective testing solutions to drive the development of new and improved implants.... 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 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 »

New Trauma Technologies Emerge to Treat Infections

by Hannah Corcoran | 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 »

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 »

Surface Treatments: Microporous Structures, Nanoscale and Additive Manufacturing

by Chris Mosby | Apr 2016

Coatings and surface treatments that encourage bony ingrowth are as popular now as ever. The technologies that allow for such growth, however, are changing. As additive-manufactured implants and nanotechnology allow for new forms of coatings, companies are starting to experiment with these technolog... 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 »

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 »

What Does it Take to Innovate?

by Hannah Corcoran | Dec 2015

In a highly regulated, cost conscious industry, a roadmap to innovation is as important as the type of innovation itself. Companies large and small need to do the following to successfully meet market expectations: allocate money, leverage data and consult FDA.... Read more »

A Look into Trauma Trends: Surgeon and Industry Perspective

by Hannah Corcoran | Dec 2015

According to surgeons and industry interviewed by BONEZONE, trends in trauma center on the rise in hip fractures, challenges of treating osteoporosis and pelvis fractures, the emergence and need for specialty plates and a place for biologics to enhance bone healing.... 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 »

How to Build the R&D and Marketing Relationship for a Successful Product Launch

by Tim Jeavons | Dec 2015

The power struggle that often plays out between R&D and marketing teams adds time, resources and costs to the product development process, and can hurt a product’s success. Teams that are able to work together will find new ways to evolve the process and shorten time to market.... 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 »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 2015

Involvement with numerous FDA inspections over the years has given me, I think, a unique perspective on design control trends—specifically, major design issues discovered during FDA inspections.... 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 »

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 »

Surgeon Seeks to Market 3D Printed Implants on Demand

by Hannah Corcoran | Sep 2015

Richard Hurley, M.D., pictures a world where surgeons actually design and 3D print implants in their office. To achieve this, he started Conceptualiz Inc. in 2012.... Read more »

Smith & Nephew’s Syncera Focuses on Organization of OR Instruments

by BONEZONE | Aug 2015

Smith & Nephew’s Syncera business unit acquired two assets from S2 Interactive, a surgical software development company, to offer customers the ability to access and manage data from the instruments used during a procedure.... Read more »

Demand to Reduce Consigned Inventory Leading to Instrumental Changes in OR

by Hannah Corcoran | Aug 2015

Device manufacturers increasingly seek to streamline their instrument inventories, due to top down demands for simpler, more cost-effective solutions. These requests have funneled down to their supplier partners, who have offered perspective on these industry changes.... Read more »

New Factors Challenge Traditional Testing Requirements

by Hannah Corcoran | Aug 2015

For orthopaedic device manufacturers, new concerns are cropping up during the device testing process due to regulatory changes and the emergence of new materials and technologies in the industry.... 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 »

Getting Lean: Strive for Built-in-Quality

by BONEZONE | Jul 2015

During his OMTEC presentation, Joe Mazzeo pinpointed the principles necessary to build a culture of inherent quality, stressing strong leadership and cultural tenets to drive lean manufacturing and create value.... Read more »

Product Spotlight: Arthroscopy and Soft Tissue Repair

by Julie A. Vetalice | May 2015

Here, we present highlights from a variety of technologies cleared and launched during 2014 and 2015 across traditional and biologic approaches.... Read more »

U.S. Registry Offers New TJR Data

by BONEZONE | May 2015

Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement or FORCE-TJR, is a four-year, $12 million project funded by the Agency for Healthcare Research and Quality that establishes a comprehensive database on total hip and knee replacement patients and outcomes.... Read more »

New Software and Manufacturing Techniques Push Custom Implant Expansion

by Hannah Corcoran | May 2015

New technology has increased the use of custom implants and instruments in orthopaedics. Consider these factors if you're thinking about incorporating custom implants into your portfolio.... Read more »

What Would You Tell a Young Engineer?

by Randy W. Rapin | Apr 2015

In preparation for OMTEC, I asked the LinkedIn Medical Devices Group members: If you had ten minutes to speak to a group of young engineers, what would you share that could not easily be found in a Google search? The question received 41 comments in ten days.... 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 »

Amedica’s Clinical Results Show Silicon Nitride Achieves Same Fusion Rate as PEEK

by BONEZONE | Apr 2015

Interim results from the CASCADE clinical trial indicate that silicon nitride composite interbody spinal devices alone, without bone graft or synthetic bone void filler, achieved similar fusion rates and clinical scores as patients implanted with traditional spacers using autograft.... Read more »

New Technology Doubles Tissue Life

by BONEZONE | Mar 2015

Researchers at the University of Missouri School of Medicine have developed a new technology that reportedly more than doubles the storage life of bone and cartilage grafts from organ donors.... Read more »

Hip: New Standards Set to Measure Taper Junction Geometry

by Christian Maul, Ph.D. | Feb 2015

Taper junction has come into the spotlight as a source of hip joint failure. Coordinate measuring machines can provide fast, detailed and accurate measurements during the R&D process and are making their way into testing standards.... Read more »

Researchers Study Nanostructures to Allow Biocompatibility Between Metal and Human Bone Tissues

by BONEZONE | Jan 2015

Scholars at The Research Center for Advanced Materials are studying the use of nanostructures to manufacture implants needed in Mexico.... Read more »

Trending Technology: Metal Injection Molding

by Hannah Corcoran | Dec 2014

Metal injection molding has garnered attention in the orthopaedic industry, due to the technology’s ability to produce complex shapes at high production rates and decreased costs.... Read more »

21 Notable Products from 2014

by BONEZONE | Dec 2014

What new products made your list of most innovative in 2014? Here is a list of some of the more innovative technologies released within their market segment.... Read more »

AJRR Releases Annual Report on Hip and Knee Arthroplasty

by BONEZONE | Dec 2014

Report data covers 43,823 primary revision procedures, reflecting 4.5 percent of joint replacements conducted every year in the U.S.... Read more »

Spine Product Launches in 2014

by BONEZONE | Oct 2014

Spine companies launched more than three dozen products between January and August of this year. To better understand market trends and what you can expect to be featured at NASS, a partial list of products, their indications and geographic availability follows.... 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 »

Center for Disruptive Musculoskeletal Innovation Launched by Industry and Academia

by BONEZONE | Jul 2014

The Center for Disruptive Musculoskeletal Innovations (CDMI) seeks to jointly define issues that hinder innovation and ideal patient outcomes, then use university resources to identify potential solutions. These solutions will be pursued with a common funding pool that supports graduate student rese... Read more »

Biomaterials Derived from Beer-brewing Waste May Have Use in Bone Regeneration

by BONEZONE | Jul 2014

Using wastes generated by the brewing of beer, researchers have developed biocompatible materials that may be used to create scaffolds upon which bone may regenerate.... Read more »

The Starting Line: Turning the Corner with a Device Concept

by John Gagliardi | Jul 2014

New orthopaedic device concepts from surgeon entrepreneurs and novice inventors often hit snags when facing the reality of the regulated industry. Understanding the barriers in each step of commercialization yields a more successful outcome.... Read more »

What to Consider When Converting Parts from Machined to Molded

by Jeff Randall | Jul 2014

Reduce cost AND increase quality: these requirements have device companies rethinking the manufacturing process. Discuss these factors when choosing between machined vs. molded parts.... Read more »

FDA to Host Public Workshop on Additive Manufacturing

by BONEZONE | Jun 2014

FDA will host a forum to address scientific and technical challenges posed by the additive manufacturing process used in medical devices.... Read more »

Study: U.S. Demand for Total Joint Replacement Remains Steady

by BONEZONE | May 2014

A new study showed that the economic downturns in the 2000s did not substantially influence the national growth trends for hip and knee arthroplasty in the U.S. The study, which appeared in The Journal of Bone and Joint Surgery, also predicts that the demand for total joint replacement will surge th... Read more »

Design Controls: A 17-Year Learning Curve

by John Gagliardi | May 2014

Developing a new device and introducing it into production are very complex tasks. Thorough planning, process control and design controls are essential to ensure that errors and important aspects aren’t left undone.... Read more »

Design for Manufacturability: Meeting the Needs of the Missing Customer

by Sean Miller | May 2014

Design for manufacturability is an input into the design that may or may not benefit the manufacturing process. As an engineering team, look at DFM as design for manufacturing as opposed to manufacturability.... Read more »

Sterilization: How to Validate Novel and Non-Traditional Processes

by Robert Packard | Apr 2014

Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation.... Read more »

IlluminOss Presents Novel Approach to Fracture Fixation

by BONEZONE | Apr 2014

Implanted in about 400 patients to date, IlluminOss Medical's PBSS is a deviation from traditional hardware used in fracture fixation technologies. BONEZONE spoke with the company's CEO about the technology and plans to gain market share.... Read more »

Coatings: Trends and Technologies in the Orthopaedic Industry

by BONEZONE | Apr 2014

As the orthopaedic industry has evolved, so too have coatings for implants and instruments. BONEZONE queried five companies to better understand trends in coatings.... 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 »

Researchers Develop Surface Treatment to Reduce Infection

by BONEZONE | Mar 2014

Researchers at Aalto University are developing a method of analyzing surface treatment processes to reduce the risk of infection.... Read more »

Defining Innovation

by BONEZONE | Dec 2013

What is innovation? It’s not just one thing. Read what orthopaedic professionals had to say on its definition and development.... Read more »

Rising Obesity Rates Driving Surge in U.S. TKR

by BONEZONE | Dec 2013

The rise in obesity rates in people under age 65 appears to be having a dramatic influence on the number of total joint replacement surgeries in the U.S., contrary to the belief that Baby Boomers and weekend warriors are spurring the rise in the procedures.... Read more »

Surgeons Describe Anterolateral Ligament in the Human Knee

by BONEZONE | Dec 2013

Knee surgeons in Belgium have provided the first full anatomical description of a human knee ligament that may play a role in anterior cruciate ligament tears. Research indicates that the anterolateral ligament is present in 97% of all human knees, and that pivot shift is caused by an injury in that... Read more »

Postmarket Surveillance and Vigilance: Making Risk-based Decisions

by John Gagliardi | Dec 2013

Medical device risk management is not a one-time project. Implementing the following steps will ensure review and risk assessment takes place throughout the life of the device.... Read more »

ACL Injuries Six Times More Likely after Reconstruction

by BONEZONE | Dec 2013

Studies suggest that athletes who have undergone anterior cruciate ligament (ACL) reconstruction are six times as likely to require another ACL surgery within 24 months as someone who has never experienced an ACL tear.... Read more »

Risk Management: The Science of Minimizing Uncertainties

by John Gagliardi | Oct 2013

The success of a risk management process in medical device manufacture lies in an early start in design and use of the life cycle approach in continuum. Here is how to establish, document and maintain risk management procedures.... Read more »

The Anatomy of a Successful Design Plan

by Robert Packard | Oct 2013

Did your latest project plan end with another line extension and the cold reality that your team was eight weeks behind? These six steps will allow you to master the design and construction of medical device design planning.... Read more »

A Natural Fix: Absorbable Textiles Improve Reconstruction from the Inside Out

by Todd Blair | Oct 2013

Slowly and steadily, biomedical textiles are garnering increasing attention from OEMs across all therapeutic sectors. As the range of biomaterials proven for implant performance widens, developers are taking advantage of new ways to build implants.... Read more »

ACL Injuries More Common after Reconstruction

by BONEZONE | Aug 2013

Studies suggest that athletes who have undergone ACL reconstruction are 6x as likely to require another ACL surgery within 24 months as someone who has never experienced an ACL tear.... Read more »

Need for Data in Unproven Implants

by BONEZONE | Aug 2013

A review of data found registry reports are accurate in providing information about hip and knee arthroplasty devices, though researchers expressed concern about the use of devices still “unproven,” without long-term survivorship data.... Read more »

Cutting Instruments: Safe and Effective Design

by Peter Bayer | Jul 2013

Cutting tools can look similar, but they don’t all perform alike. Consider these design and manufacturing processes for the best performance.... Read more »

Bone Substitutes: Swapping Autograft for Bioactive Glass

by BONEZONE | Jun 2013

Studies show bioactive glass is a viable treatment for complete bone repair. BONEZONE spoke with BonAlive about the science behind the technology.... Read more »

Imaging in Medical Device Manufacturing

by Tim Kulbago | May 2013

Manufacturers are facing significant pressure for more efficient, cost effective and higher quality production of their products. Imaging hardware and custom analytical and operational software can deliver strong manufacturing ROI, as well as a competitive price and quality advantage.... Read more »

Manufacturing Implants with Residual Compression

by Doug Hornbach | May 2013

Since implementing Low Plasticity Burnishing (LPB®) Exactech hasn’t experienced a single failure from a processed hip. Here is how adding a layer of residual compression to a metallic device part has been shown to slow fatigue crack initiation and growth.... Read more »

Case Study: Moist Heat Sterilization of Reusable Device and Tray System

This case study, “Sterilization by Moist Heat Sterilization at 132C of Reusable Device and Tray System,” systematically investigates the role of steam, heat and load configuration in the validation of moist heat sterilization and drying.... Read more »

FDA Recognizes Computer Simulated Performance Data in Device Evaluation

by BONEZONE | Apr 2013

FDA seeks to draft verification and validation guidelines in response to more medical device manufacturers using computer modeling and simulation.... Read more »

Lessons Learned From Metal-on-Metal Implants

by Robert Packard | Mar 2013

The FDA is only the latest regulatory body to take investigative action on metal-on-metal implants. What follows is a two-part primer on metal implant test method results and risk analysis steps OEMs should consider as fallout continues over the use of MoM implants.... Read more »

The Future of Additive Manufacturing in Orthopaedic Implants

by BONEZONE | Mar 2013

Additive manufacturing is expected to be a $3.5 billion industry by 2017. Orthopaedic device manufacturing has the ability to grow with the application.... Read more »

Breakthrough in NiTiNOL Use in Implants

by BONEZONE | Feb 2013

The use of nickel titanium or NiTiNOL in large orthopaedic devices has been limited in basic materials and devices. MedShape overcame these technological challenges to produce its new ankle arthrodesis nail.... Read more »

Supplier Roundtable, Part II: Materials Suppliers Prepare for 2013

by BONEZONE | Jan 2013

More responses from suppliers! Pressures from material costs and Federal regulations are expected to increase in 2013. To ensure commercialized product quality, safety and performance, suppliers and OEMs will need to maintain vigilant communication and share industry awareness. Read on for material ... Read more »

The Quality Review Board: A Conduit for Success

by John Gagliardi | Dec 2012

Your Quality Review Board exists to ensure continual improvement to your Quality Management System. How do they stack up as a conduit for the success of your company’s directives?... Read more »

Aerospace Materials and Orthopaedic Applications: Opportunities and Challenges

The evolution of biomaterials adopted for orthopaedic use might well be described as slow and incremental. In this article, we will address how aerospace materials, particularly composites, might have direct applications to orthopaedic practice due to advanced material properties.... Read more »

Strategic Planning for Regulatory Compliance

by Robert Packard | Dec 2012

Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality Plan to prepare for these changes? The principles in this article apply to all medical device manufacturers, any device and every new and revised regulatory requirement. The purpose of th... Read more »

Selecting an Imaging Contract Research Organization for Orthopaedic Clinical and Preclinical Research

by Brett Hoover, MS | Dec 2012

When the success of an orthopaedic study is at stake, sponsors want an imaging contract research organization that can help accelerate the journey from bench to bedside. A sponsor should be confident that the ICRO can support its imaging-related efforts in every capacity. The following&nbs... Read more »

Improving Manufacturability by Properly Applying GD&T as an Effective Design Tool

by Joe Soistman | Dec 2012

Most modern manufacturers in all industries now employ Design for Manufacture in the design process. Efforts range from simple requests for larger tolerances to thorough review of design intent by collaborative teams of design, manufacturing and quality disciplines. Without careful attention to the ... Read more »

Supplier Roundtable: Materials Suppliers Prepare for 2013

by BONEZONE | Nov 2012

Pressures from material costs and Federal regulations are expected to increase in 2013. To ensure commercialized product quality, safety and performance, suppliers and OEMs will need to maintain vigilant communication and share industry awareness. Read on for material suppliers'  guidance for O... Read more »

Suppliers and Service Providers Offer Innovative Solutions

by BONEZONE | Nov 2012

Innovative products and services are produced every day. Finding them is the hard part. We invited suppliers and service providers to share their solutions that serve your specific challenges. Read on to see the innovations that can serve your needs.  ... Read more »

Imaging Modality Review for Orthopaedic Clinical Research

“Garbage in, garbage out,” goes the saying. An upfront understanding of how imaging modality options best support crucial research data will avoid unnecessary “data garbage” as research is underway. Starting a new clinical study with the end in mind will allow you to select the right imaging... Read more »

Complaints: A Second Chance to "Make it Right"

by John Gagliardi | Oct 2012

Customer complaints can give medical device companies a wake-up call when they're not achieving their fundamental purpose: that is, meeting customer requirements. If orthopaedic companies don't deliver what they promise, i.e. meet the customer's requirements (the root cause of most complaints) the c... Read more »

Quality by Design: Incoming Acceptance Activities of Purchased Materials

by John Gagliardi | Aug 2012

All manufacturers of orthopaedic medical devices must establish and maintain procedures to verify that all products meet their specifications and acceptance criteria. Acceptance activities can include, but are not limited to, inspection and testing, the use of certificates of analysis, supplier audi... Read more »

In Vivo Bone Growth Assessment in Preclinical Studies and Clinical Trials

by Amit Vasanji, Ph.D. | Aug 2012

The significance of in vivo investigation has become increasingly important as bone substitutes have grown in structural and compositional complexity. The diversity of parameters currently expected from osseointegration studies, combined with patient or animal population-based variability in reactio... Read more »

UHMWPE for Total Joint Arthroplasty: Past, present and future

Total joint arthroplasty involves the replacement of native articulating joints, such as the hip, knee, shoulder and ankle, with artificial components. In the U.S., these artificial joints are normally composed of plastic and metal. According to THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®, 2.9 million ... Read more »

Wireless Implantable Sensors with No Electrical Connections Enable the Next Generation of Smart Orthopaedic Implants

by Eric Ledet | Jun 2012

Smart implants can provide objective information about the progression of healing after orthopaedic surgery. These data can help guide post-operative care, foster better outcomes and reduce lost work time. The technology exists to transform traditional orthopaedic implants into smart implants. So wh... Read more »

Imaging Analytics and the Changing World of Orthopaedics

Imaging analytics is the extraction of meaningful quantitative information from digital images using software-based image processing and analysis techniques (i.e., algorithms). These techniques can be part of standard software suite, or custom-tailored to a specific application using a combination o... Read more »

Imaging Analytics: Optimizing Time Efficiencies

by BONEZONE | Dec 2011

ORTHOWORLD is pleased to announce the inclusion of ImageIQ in the educational session lineup for OMTEC 2012. Prior to its formation as a stand-alone company, ImageIQ operated for over a decade as a core service within the Cleveland Clinic. Today, ImageIQ offers a unique solution for biotechnology a... Read more »

Leading Strategic Initiatives Blog: Tools and Insights for Turning Vision into Results

by BONEZONE | Dec 2011

Greg Githens has substantial direct experience in designing, developing, leading and coaching the direction of strategic initiative programs. BONEZONE readers first met Mr. Githens in 2008 at his OMTEC workshop, “Practices and Skills for Innovation and High-Speed New Product Development.” Since ... Read more »

Planning for the Unpredictability of Change

by John Gagliardi | Dec 2011

...and it Begins   Change, defined: The act, process, or result of altering or modifying  Change is inevitable and sometimes even predictable but, then again, that depends. If you’re an orthopaedic device company obligated to follow the edicts of 21 CFR, Part 820 and ISO 13485:2003, t... Read more »

Quality, Speed, Price: Pick Three

by Bill Greene | Dec 2011

A keynote address at the 7th Annual Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC) in June 2011 forecasted several changes in FDA regulatory policy and a concomitant evolution in the medical device market. The trend toward “negative innovation” is slowing the adopti... Read more »

Innovation, Advanced Development, IP & Competency: Four Inescapable Product Development Trends

by Brad Goldense | Oct 2011

The “Innovation Era” is causing tangible changes in orthopaedic research & development (R&D) and product development. Small amounts are being shaved off traditional new product budgets for reallocation to advanced projects believed to have a higher return on innovation. These reallocatio... Read more »

Integrating Internal Strategies to Impact a Successful Product Launch

by Kelli Hallas | Aug 2011

Your company is ISO 13485 certified and has internal processes in place. Individual departments have well-established SOPs. Yes, you have successfully introduced several products to market on a project-by-project basis. If it’s not broken, why fix it? Why the need to integrate strategies? “Stra... Read more »

The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties

by John Gagliardi | Aug 2011

FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do not have an adequate quality system. An evaluation of approximately 2,400 manufacturers that received cGMP-QSR inspections by FDA showed that manufacturers with an adequate qu... Read more »

Got GD&T? Exploring the Importance of Advanced Mechanical Inspection

by Kelly Lucenti | Jun 2011

Medical device manufacturers spend big dollars on research and development of new products. In many cases, the manufacturer relies on a series of vendors to produce the devices that are used in a variety of surgical procedures. One of the biggest challenges for a medical device maker, then, is to en... Read more »

Engineering Plastics Deliver Cost/Performance Advantages as Metal-Replacement Option

by Margarita Alonso | Mar 2011

High-performance thermoplastics are enjoying strong growth as a replacement for metal in a broad range of medical and healthcare applications. These high-performance materials are known for their mechanical properties and are proven in their unique ability to cut system costs through lower productio... Read more »

Corrective and Preventive Action: What Does FDA Look For During Inspection?

by John Gagliardi | Mar 2011

This is a first of a series of articles addressing the topic of what FDA seeks during an inspection. This article also serves to introduce my lecture and workshop scheduled for OMTEC 2011, relative to FDA inspections. (Further details are available following this article.) The orthopaedic industry ... Read more »

A New Inspection Paradigm

by Bill Greene | Mar 2011

Inertia exists across numerous industries. Medical device manufacturers aren’t the only companies imbued with a sense that, “If we just do things the way we’ve always done them, we’ll be fine.” However, in an age of tightening healthcare budgets and the potential for tough choices to be ha... Read more »

Design Controls: Design Transfer, Changes and the Design History File

by John Gagliardi | Dec 2010

In this issue, we wrap up a series of six articles focused on the design controls process from a standpoint of design transfer, changes and the design history file (DHF) in the orthopaedic medical device marketplace. I hope that you have enjoyed reading the previous articles, which are all available... Read more »

Loukas Medical, Systematic Displacement Screw (SDS)

by Jim Rinner | Dec 2010

Loukas Medical, Inc. is seeking partnerships to license the SDS for their orthopaedic screw applications. Approximately 6.8 million fractures that need medical attention occur in the U.S. each year. Many of these require bone screws to stabilize the fractured bone. Add to that the many orthopaedic ... Read more »

Kapstone Medical, Spherofix™ Technology

by John Kapitan | Dec 2010

Kapstone seeks to license Spherofix technology to qualified partners. A unique technology has been developed which allows for exceptional mechanical fixation of screw/plate fixation with the added benefit of adjustable angulation. Fixation is achieved through a simple twisting motion. The technol... Read more »

3D Technology Improves Surgical Implants and Procedures

Three-dimensional (3D) technologies are famous for improving product design, manufacturing, even the quality of movies. But application in medical fields has been a much slower process. While uptake in the use of 3D for orthotic devices is visibly on the rise, 3D for improving orthopaedic implant de... Read more »

Outcome Measures in Joint Replacement by Physical Activity Monitoring: Pre-pilot Study

by Jon L. Conroy, BSc. | Dec 2010

Success rate figures for total joint arthroplasty are typically based on revision rates, and do not reflect patients’ satisfaction or quality of life. Neither do they take into account the patient’s physical mobility after a surgical procedure.1 In order to reduce the need for revision, many stu... Read more »

Design Controls: Design Verification and Validation

by John Gagliardi | Sep 2010

This editorial is the fifth in a series of six articles focused upon the design controls process from a standpoint of design verification and design validation in the orthopaedic medical device marketplace. First, let’s review some pertinent definitions of terms from the 21 CFR, Part 820.30 and IS... Read more »

Injectable Hydrogel-based Medical Devices: “There's always room for Jell-O”

"There's always room for Jell-O." —Peter Venkman, Ghostbusters II, 1989. The human body is an intricate combination of hard and soft tissues, the interaction of which leads to its amazing flexibility and durability. To date, the vast majority of implantable biomedical devices use rigid materials ... Read more »

Design Controls: Design Review

by John Gagliardi | Jun 2010

This is the fourth in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device marketplace. Because the design process is controlled and driven by a cross-functional group of individual... Read more »

Design Controls: Inputs and Outputs in Synergy

by John Gagliardi | Mar 2010

This is the third in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device market. Sometimes called the requirements phase, design inputs are the starting point of understanding the ... Read more »

A Framework for Evaluating Opportunities in a Dynamic Market

by Mark Siders, Ph.D. | Mar 2010

Many firms seek growth opportunities to either solidify already solid performance or to bolster sagging revenues. I offer the following insight into some of the primary motivations that would lead a firm to consider new opportunities, as well as some criteria that may be useful in evaluating opportu... Read more »