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Articles Tagged "omtec"

Big Data, Biologics and Failure Rates Among Significant Interests for Surgeon

by BONEZONE | Oct 2018

"There has never been a greater need for the lowest rates of failure possible," says Dr. Adolph J. Yates. "Proven devices with low revision rates might be ... the safest bet compared to new designs that have yet to be vetted in an after-market environment."... Read more »

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

by BONEZONE | Jul 2018

"The majority of devices have become commodities," says Dr. Peter Althausen. "Devices coming to market have not demonstrated improved outcomes, yet carry hefty price tags and are not affordable. Clearly there’s no winning argument to pay more for devices that do not improve outcomes."... Read more »

Surgeons Seek Innovation in Instruments, Delivery of Care

by BONEZONE | Jul 2018

OMTEC’s Closing Panel brought together surgeon executives and entrepreneurs with diverse market backgrounds—joint reconstruction, spine and trauma—to provide perspective on patient-specific instruments, single-use devices, ASCs and more. ... Read more »

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

by BONEZONE | Jul 2018

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

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

by BONEZONE | Jun 2018

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

Hospital, Surgeons Provide Insight Into Purchasing Priorities

by BONEZONE | Jun 2018

The OMTEC® 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure from public and private payors, bundled payments, value analysis committees and outpatient surgeries. ... Read more »

NN Life Sciences to Exhibit at OMTEC® 2018

by BONEZONE | Jun 2018

The June 12-14 global orthopaedic conference marks the first joint appearance by NN Life Sciences and recently-acquired Paragon Medical.... Read more »

Element's Andrew Smith, PE, to Bring Additive Manufacturing Expertise to OMTEC® 2018

by BONEZONE | May 2018

Smith will present mechanical test methods in AM as part of the event’s GE Additive Tech Center.... Read more »

Optimizing Your Supply Chain with Science, Data and People

by BONEZONE | May 2018

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

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

by BONEZONE | Apr 2018

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

Croom Precision Medical Seeks Entry into U.S. Market

by BONEZONE | Aug 2017

Croom plans to expand in the next few years through the addition of a new R&D admin building to house 60 additional employees, mostly engineers.   ... Read more »

Upgrade Your Orthopaedic Toolbox to Achieve Your 2017 Priorities

by BONEZONE | May 2017

Companies are exploring myriad approaches to diversification, from launching new brands to entering new markets to engaging in acquisitions. These paths are often directed by company size and focus.... Read more »

Leading Supply Chains Adopt These Principles

by BONEZONE | May 2017

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

Value Analysis Committees, EU’s MDR Highlighted in OMTEC Surgeon Keynote

by BONEZONE | Apr 2017

Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration amongst customers within the supply chain in order to remain innovative and competitive.... Read more »

Revisiting Predictions: Orthobiologics, Payors and ASCs

by BONEZONE | Dec 2016

Robert S. Bray, Jr., M.D., revisits predictions from his OMTEC 2014 keynote—talking sustainable medicine, orthobiologics, care delivery and what can be gained from a relationship between OEMs and insurers.... Read more »

One Answer to Your Postmarket Challenge: Planning

by Vicki Anastasi | Dec 2016

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start.... Read more »

Jarvis Surgical Honored With State Economic Impact Award

by BONEZONE | Oct 2016

During 2015, the company invested $1.7 million in a 15,000-square-foot facility and supported the creation of 15 new jobs.... Read more »

Focus: The Need for Innovation in Orthopaedics is Real

by Hannah Corcoran | Sep 2016

Challenges in orthopaedics have created new opportunities to innovate. Here, we look at two: delivery of care and manufacturing techniques.... Read more »

5 Questions on the Adoption of Additive Manufacturing

by BONEZONE | Aug 2016

The orthopaedic industry has become more invested in additive manufacturing, as demonstrated by product launches, partnerships and FDA’s recent guidance document on the technology. But, what do surgeons think about it?... Read more »

Instrument Testing: How to Capture the Best Data

by BONEZONE | Jul 2016

Vagueness in standard methods and regulatory guidance surrounding instrument testing and validation has left OEMs questioning what best practices to apply to their devices.... Read more »

OMTEC 2016: Download Presentations Critical to Your Success

by BONEZONE | Jun 2016

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

CoorsTek Acquires Philips’ Ceramics Operation in the Netherlands

by BONEZONE | Jun 2016

CoorsTek has acquired Philips’ ceramics operations in Uden, The Netherlands. Through this acquisition, CoorsTek expands its strategic partnership with Philips and will serve both Philips and other regional customers from Uden. Adding Uden extends the CoorsTek footprint to a dozen European ma... Read more »

Lowell Adds Quality Manager

by BONEZONE | May 2016

Lowell announced that Ed Yaris has joined the company as its Quality Manager. Yaris comes to Lowell with experience in Metrology, Management and CMM Software development, including leadership positions at National Security Technologies, Helmel Engineering Products, Renishaw and GE. Yaris is a membe... Read more »

Arcam Builds New Powder Manufacturing Plant

by BONEZONE | May 2016

Arcam, supplier of Additive Manufacturing (AM) equipment, announced that its powder manufacturing subsidiary AP&C in Montreal, Canada, is building a new powder manufacturing plant. The new facility will provide manufacturing redundancy, short term capacity increase and long term expansion capa... Read more »

Supply, Cost and Quality Lead Concerns among Raw Materials Providers

by BONEZONE | Mar 2016

Supply and demand factors, price pressures and enhanced regulatory scrutiny are expected to influence the raw materials portion of the orthopaedic supply chain in 2016. Eight of the 27 raw material suppliers exhibiting at OMTEC weighed in on these themes.... Read more »

Handling Disruption: The Need for Proprietary Business Models

by BONEZONE | Feb 2016

The economic and regulatory environment for medical devices is changing. OMTEC Keynote Speaker Bill Tribe, Partner at consulting firm AT Kearney, discusses ways to protect and grow your business.... Read more »

Laser Processing: A Guide to OMTEC 2016 Exhibitors

by BONEZONE | Feb 2016

As we approach OMTEC 2016, BONEZONE is taking a closer look at the exhibitors you’ll meet at the event. In this round: Laser Processing.... Read more »

MedTorque Launches TRI-GEAR Surgical Ratchets in Europe

by BONEZONE | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Executives Warn of Paradigm Shift in R&D Spend

by Carolyn LaWell | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Getting Lean: Strive for Built-in-Quality

by BONEZONE | Jul 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

What Would You Tell a Young Engineer?

by Randy W. Rapin | Apr 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

OMTEC 2015 Preview: Meet 25 Longtime Exhibitors

by BONEZONE | Apr 2015

Of 2015 OMTEC exhibitors, nearly 20 percent have presented their solutions at the conference since its early days. Discover who these companies are and what they bring to OMTEC year after year.... Read more »

OMTEC 2015 Preview: Meet First-time Exhibitors

by BONEZONE | Mar 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Uncover Opportunities in Your Supply Chain Challenges

by Hannah Corcoran | Nov 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Orchid to Present on Coating Implants at OMTEC 2014

by BONEZONE | Jun 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Nelson Laboratories Joins the Orthopedic Discussion on Sterile Packaging Validation at OMTEC 2014

by BONEZONE | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

High-Demand Education Featured at OMTEC 2014

by BONEZONE | Feb 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

BONEZONE Authors Present Solutions at OMTEC 2013

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ORTHOWORLD Announces FDA Official to Serve as Panelist at Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC)

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Supply Chain Development in Orthopaedics

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The State of American Medicine - Orthopaedics and the Vampire Economy

by BONEZONE | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Market Growth Rates in Orthopaedics - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Big Government's Argument for Government-run Medicine - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

An Environment of Oppresive Taxation and Overregulation - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

What are the Symptoms of America's Disease of Decline? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

What are the Economic Signs of America's Disease of Decline? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

What is the Diagnosis? How do we Survive? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

What is the Outcome? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Conclusions: The Tipping Point - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Medical Device Excise Tax - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Trends in Innovation and R&D Investment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Supply Chain Development in Orthopaedics - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA - The Fly in the Ointment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Orthopaedic Industry in Five Years - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Phillips Precision Medicraft Introduces New Breakthrough Technologies at OMTEC 2012

by BONEZONE | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Join Gibraltar Laboratories in October 2012 for Seminar on Antimicrobial Practice

by BONEZONE | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

F&G Tool and Die Earns ISO 17025 Accreditation

by BONEZONE | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

A Framework for Evaluating Opportunities in a Dynamic Market

by BONEZONE | Sep 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Integrating Internal Strategies to Impact a Successful Product Launch

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

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

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Vested Outsourcing: A New Business Model

by BONEZONE | Aug 2011

My first book, Vested Outsourcing: Five Rules that Will Transform Outsourcing, [1] centered on a better, more collaborative way to outsource by outlining the need for business relationships based on trust, collaboration and working together to achieve mutually beneficial goals. Extensive research b... Read more »

Mauricio Arellano, President, Greatbatch Medical

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

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

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Forecasting: It’s Getting Better

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Patent Reform is On the Way…Maybe

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Reimbursement Top Ten Checklist: Understanding How Coverage, Codes and Payment Impact the Success of a New Medical Technology

by BONEZONE | Jun 2011

The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing. Manufacturing has ramped up and can accommodate distribution deadlines. The plan is perfect; what could possibly go wrong? Bottom line is this…no matter how unique or innovativ... Read more »

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

by BONEZONE | Mar 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Change Management and S&OP: Part II

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Comparative Effectiveness: From Theory to Practice

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

You May Own a Copyright and Not Know It!

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Change Management and S&OP

by BONEZONE | Sep 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

A Supply Chain Manager's Guide to Strategic Purchasing, OR How to be on top of things instead of having things on top of you!

by BONEZONE | Sep 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: Design Verification and Validation

by BONEZONE | Sep 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Truth or Myth: Does an International Patent Exist?

by BONEZONE | Sep 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Forrest R. Whittaker, Chief Executive Officer, Avalign Technologies, Inc.

by BONEZONE | Jun 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Enter 2010 and Leave Fear Behind

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Filing a Provisional Patent Application – Applicant Beware

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Vested Outsourcing: Game Changing Rules for Outsourcing

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Nine Naive Notions About S&OP

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Reducing Costs in the Supply Base

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Controls: Inputs and Outputs in Synergy

by BONEZONE | 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 »