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Articles Tagged "oem"

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 »

Prototyping: OEM Survey Highlights Challenges

by BONEZONE | May 2018

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

MedTech Momentum Launches Video Production Studio

by BONEZONE | Dec 2017

The venture covers a wide range of video formats for medical companies to choose from.... Read more »

Elos Medtech’s Advantage Lies in Nimble Approach to Serve Orthopaedic Customers

by BONEZONE | May 2017

As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S. based Onyx Medical in 2015, effectively establishing a presence in the largest orthopaedic market.... Read more »

Exit Interview: Longtime Orchid CEO Mike Miller Retires

by BONEZONE | Mar 2017

In fewer than 18 years, Mike Miller founded and led Stealth Technologies from a five-man operation supplying high-performance auto parts to its existence today as Orchid Orthopedic Solutions, one of the larger contract manufacturers in orthopaedics.... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... Read more »

Suppliers Prioritize Additive Manufacturing Initiatives to Start 2017

by BONEZONE | Mar 2017

Carpenter, GE, Materialise and Siemens announce collaborations, acquisitions to address additive technology.... Read more »

China’s Medtech Policy Sets Path for Orthopaedic Manufacturers

by BONEZONE | Feb 2017

The Chinese government has prioritized medical device development, as well as local and international investments by domestic device companies. These initiatives, along with shifts in OEM to hospital distribution channels and newly-structured tiered healthcare, are expected to affect and shape the o... Read more »

Additive Manufacturing Experts Talk Quality

by BONEZONE | Dec 2016

Talk of the promise of additive manufacturing and 3D printing often centers on aspects of cost, speed, advanced designs, clinical outcomes. With any technology used in our highly-regulated, patient-facing industry, quality—of the process, of the machine, of the finished product, of the knowledge o... Read more »

Caltorque Medical Products Announces Addition of ISO 7 Clean Room Facility

by BONEZONE | Jan 2016

Caltorque Medical Products announced ISO 7 certification at its production clean room facility. The HEPA-filtered clean room is used to manufacture single procedure Torque Limiting, Ratcheting, and Procedural Package Surgical kits for orthopaedic implant OEMs globally. Recently, the company added th... Read more »

Conflict Minerals Due Diligence: Strategies for a Successful Second Filing

by Hannah Corcoran | Jan 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 »

Zoning In with Mark Augusti

by BONEZONE | 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 »

How to Get the Most Out of Your IP Firm

by John W. Boger, Esq. | 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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System... 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 »

Company Financials: Orthopaedics and Spine

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 »

Company Financials: Orthopaedic and Spine

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 »

1Q11 Company Financials: Orthopaedic and Spine

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 »

2010 Company Financials: Orthopaedic and Spine

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 »

2010 Company Financials: Orthopaedic and Spine

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 »

3Q10 Company Financials: Orthopaedic and Spine

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 »