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Articles in category: Research & Development

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 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.... 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, the fre... 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 »