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Articles Tagged "manufacturing"

Successful Medical Device Design Transfers Hinge on Advance Planning

by BONEZONE | Apr 2018

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

Medical Component Specialists Introduces Mandrel Quick Ship Program

by BONEZONE | Apr 2018

The Quick Ship Program provides expedited delivery of both French and standard catheter mandrels.... Read more »

Baum Precision Machining Adds 5-Axis Machine

by BONEZONE | Apr 2018

The company specializes in CNC milling and serves several industries, including medical.... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by BONEZONE | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »

AcceLINX Adding Three Experts to Consultant Roster, Collaborating With AMB Surgical

by BONEZONE | Mar 2018

The musculoskeletal health business accelerator adds expertise focused on manufacturing/operations, reimbursement and grant writing.... Read more »

FMI Instrumed Expanding Additive Operations

by BONEZONE | Mar 2018

The company is adding a fifth 3D printer to its manufacturing facility.... Read more »

Supplier Talks: Precision, Accuracy Among Swiss Machining Benefits

by BONEZONE | 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 »

Renishaw’s SFP2 Improves Surface Measurement Ability of REVO System

by BONEZONE | Feb 2018

  This surface finish measurement probe works with the company’s REVO 5-axis measurement system... Read more »

IHI Ionbond Announces Series of Strategic Investments

by BONEZONE | Jan 2018

New coating equipment will be utilized as well as new cleaning facilities in its coating center... Read more »

GE Additive Opens Munich Customer Experience Center

by BONEZONE | Jan 2018

The $15 million center will employ up to 50 employees within the 29,000-square-foot facility.... Read more »

Fort Wayne Metals Acquires G&S Titanium

by BONEZONE | Jan 2018

G&S specializes in titanium and specialty alloy wire and bar drawing.... Read more »

Arcam EBM Expanding Into New Facility

by BONEZONE | Jan 2018

The Härryda, Sweden space will open in 1Q19 ... Read more »

Forecreu Investing US $6MM in French Plants

by BONEZONE | Dec 2017

The investment includes an upgrade of manufacturing facilities and other peripherals.... Read more »

ASTM International Seeks Partners to Launch Additive Manufacturing Center of Excellence

by BONEZONE | Nov 2017

This global innovation hub will advance AM technical standards, related research and development, education, training and more.... Read more »

Autocam Medical Honored in Massachusetts

by BONEZONE | Nov 2017

The company received a Manufacturer of the Year award.... Read more »

Medbio Expands Implant Molding Capabilities

by BONEZONE | Nov 2017

The company now features an ISO Class 7 clean room.... Read more »

Incipio Devices Expanding, Adding Personnel

by BONEZONE | Nov 2017

The orthopaedic device company is investing more than $7 million in manufacturing and research.... Read more »

Minnesota Rubber and Plastics Doubles Clean Room Manufacturing Capacity

by BONEZONE | Oct 2017

The addition includes a new Class 8 clean room at their 70,000-square-foot facility in Litchfield, Minnesota.  ... Read more »

Tegra Medical Adds Manufacturing Space in U.S. and Costa Rica

by BONEZONE | Sep 2017

Tegra Medical is responding to customer needs and demand for a strong ex-U.S. presence.... Read more »

GE Additive Seeking to Certify Production Partners

by BONEZONE | Sep 2017

To allow GE Additive to meet the growing industry demand for additive components, they are seeking to identify companies to become certified additive production centers by the end of the year.... Read more »

Orthopaedics' Talent Gap: Working to Fill the Manufacturing Void

by BONEZONE | Aug 2017

The collective brain power and skill set of the individuals within a company make that business successful. The orthopaedic industry faces hiring obstacles that hinder company and, ultimately, industry growth.... Read more »

NuVasive Ahead on In-House Manufacturing Hires

by BONEZONE | Mar 2017

The company machined 40,000 pieces in its Ohio manufacturing facility in 2016.... Read more »

FDA Update: Final Guidance on Medical Device Reporting

by BONEZONE | Jan 2017

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.... Read more »

Proper Equipment Utilization Reduces Costs and Improves Margins

by BONEZONE | Jun 2016

When it comes to reducing cost or improving margins, the first place many companies go is their suppliers. Although there may be opportunity there, often the most cost-saving and margin-improving benefits can be found on their own factory floor. A good tool to measure this is to calculate your Overa... Read more »

Building Evidence for Additive Manufacturing: What Questions Remain?

by BONEZONE | Jun 2016

In order for additive manufacturing to move from tinkering technology to widely-used process, it’s imperative to prove its long-term benefits. In May, researchers, surgeons, device companies and additive manufacturing suppliers gathered to develop guidelines to build data and support reimbursement... Read more »

Norton Introduces New Centerless Grinding Wheel

by BONEZONE | Jun 2016

Saint-Gobain Abrasives has added a new line of centerless grinding wheels to its bonded abrasives portfolio. The newly developed Norton Century45 centerless bond platform features an exclusive chemistry that improves grain retention in the wheel. Better grain retention means wheels are constructed ... Read more »

Invibio Settles FTC Antitrust Allegations Concerning PEEK Market

by BONEZONE | May 2016

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

Methods 3D Adds New 3D Printer

by BONEZONE | May 2016

Methods 3D, a subsidiary of Methods Machine Tools, announced the addition of the ProJet® MJP 3600 to its line of 3D printers and direct metal 3D printers from 3D Systems. Methods 3D has installed the ProJet MJP 3600 within its multiple technology centers across the U.S. to provide product demonstr... 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 »

Acme Manufacturing Hires Director of Engineering

by BONEZONE | May 2016

Acme Manufacturing, specialist in design and manufacturing of integrated robotic automation for polishing, buffing, deburring and grinding systems, has appointed Dan Sula, MScEng, as Director of Engineering. Sula has over 30 years of experience and success in manufacturing engineering, flexible rob... Read more »

Norton Introduces QUANTUM3 Grinding Wheels

by BONEZONE | Mar 2016

Saint-Gobain Abrasives introduced Norton QUANTUM3™ (NQ3) Depressed Center Grinding Wheels. Featuring a proprietary grain along with a tougher bond system containing a combination of fillers and bonding agents that allow for better mix quality in manufacturing, NQ3 provides faster grinding for ... Read more »

TA Instruments Announces Move of the Electroforce Group

by BONEZONE | Jan 2016

TA Instruments, manufacturer of analytical instruments for thermal analysis, rheology and microcalorimetry, announced that ElectroForce Systems Group has moved to a new facility in Eden Prairie, Minnesota. The ElectroForce Systems Group manufactures mechanical testing systems that are used to chara... Read more »

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

by Tim Jeavons | 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 »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 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 »

Outsource Innovation by Tapping into Supplier Expertise

by David Finch | Nov 2015

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

3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers

by Hannah Corcoran | Nov 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 »

Three Spine Companies Implement New Manufacturing Strategies

by Carolyn LaWell | Sep 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 »

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 »

Collaboration and Resources Needed to Close Skills Gap in the Orthopaedic Industry

by Hannah Corcoran | Mar 2015

It is often difficult for orthopaedic device manufacturers to fill certain positions, due to the technical requirements and high-level skills needed for the job. Collaboration among stakeholders is necessary to secure qualified workers.... Read more »

Asahi Intecc Drive Cable Offered in Expanded Size Range

by BONEZONE | Feb 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 »

Hip: New Standards Set to Measure Taper Junction Geometry

by BONEZONE | Feb 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 »

Trending Technology: Metal Injection Molding

by Hannah Corcoran | Dec 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 »

Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations

by Carolyn LaWell | 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 »

CoorsTek Medical Integrates IMDS and C5 Medical Werks

by BONEZONE | Oct 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 »

Greater Memphis Medical Device Council Forms to Support Industry Health

by BONEZONE | Jul 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 »

What to Consider When Converting Parts from Machined to Molded

by BONEZONE | Jul 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 »

UFP Technologies Expands Medical Manufacturing Operations in Massachusetts

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 »

Orchid Breaks Ground on New Manufacturing Site in India

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 »

Resonetics Announces New Laser Micromachining Patent

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 »

MRPC Completes Facility Expansion on the Heels of Top Workplaces Win

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 »

Increase Lean Manufacturing Improvements through Business Plan Deployment

by Joseph Mazzeo | Apr 2014

Most companies may be satisfied with continuing to utilize the lean principles that they have implemented and, through continuous improvement, work to refine and improve their performance. But there is a key next step that businesses can take to further drive lean manufacturing improvements and resu... Read more »

Zoning In with Robert Johnson

by BONEZONE | Mar 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 »

3D Printing and IP: Can They Coexist?

by John W. Boger, Esq. | Mar 2014

Analysts have predicted that by 2018, 3D printing will result in a loss of $100 billion per year in IP globally. Here is a look at why enforcing one’s IP against 3D printer infringers will be challenging.... Read more »

Pexco Expanding Manufacturing in Mexico

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 »

Auditing Process Validation & Developing Protocols

by Robert Packard | Jan 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 »

Labor Hours or Machine Hours: Which is Preferable?

by Douglas T. Hicks, CPA | Dec 2013

A manufacturer that fails to segregate indirect and support costs driven by the operation of equipment from those driven by the work of individuals will seldom arrive at product or process costs that reflect economic reality.... Read more »

Measuring and Assessing the Cost of Manufacturing Cells and Lines

by Doug Hicks | Oct 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 »

UFP Technologies Expands Manufacturing Operations in Illinois

by BONEZONE | Sep 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 »

Industry’s Achilles Heel: The Supply Chain

by Karen Conway | Aug 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 »

Unique Challenges in Instrument Manufacturing

by BONEZONE | Jul 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 »

Cutting Instruments: Safe and Effective Design

by Peter Bayer | Jul 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 »

Material Cost vs. Price Plays Important Role in Sensitive Market

by Doug Hicks | Jun 2013

Manufacturers often use a 200-year-old, outdated process to arrive at the cost of producing product. Failure to incorporate these 21st century cost components leads to inappropriate and unprofitable pricing and investments.... Read more »

Imaging in Medical Device Manufacturing

by Tim Kulbago | 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 »

Spotlight on Europe

by BONEZONE | 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 »

FDA Releases New Requirements for Combination Products

by BONEZONE | Mar 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 »

Entering the Market in Argentina

by BONEZONE | Feb 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 »

Methods Machine Introduces FANUC D21 RoboDrill Vertical Machining Centers

by BONEZONE | Dec 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 »

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

by Joe Soistman | Dec 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 »

Staffing Solutions: CNC Machinists in Training

by BONEZONE | Dec 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 »

TCR Takes Majority Stake in In'Tech Medical

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 »

Techniks Introduces Nexus Cutting Tools

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 »

Precision Edge Opens New Facility; Adds 200 Jobs in Michigan

by BONEZONE | Sep 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 »

ZL Engineering Plastics Opens New Extrusion Facility

by BONEZONE | Sep 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 »

Secant Medical Announces Company Name Change

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 »

Spectrum Plastics Increases Quick-Turn Tooling & Molding Capabilities at its Minnesota Facility

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 »

Cadence Opens 25,000 Square Foot Expansion

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 »

Arcam and Oak Ridge National Laboratory Sign Cooperation Agreement

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 »

Geomagic Expands its Global Presence into India

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 »

ANCA Offering 5-Part eCourse on Bone Drills

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 »

Greatbatch Medical Proposes Consolidation of Orthopaedics Manufacturing Sites

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 »

Polygon Solutions to Join the Southwest Regional Manufacturers Association

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 »

Greatbatch Medical Opens Orthopaedic Manufacturing Center

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 »

Precision Engineered Products Expands Medical Manufacturing Capability with New Dominican Republic Facility

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 »

Tegra Medical Announces New President/CEO

by BONEZONE | May 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 »

Sector Snapshot: The Orthopaedic OEM and Supplier Markets

by BONEZONE | Dec 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 »

Challenges in the Supply Chain

by BONEZONE | Dec 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 »

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

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 »