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November 2009


Prototyping Case by Case
Communication is paramount for prototyping firms, especially when cost is considered.
By Tim Sohn


Stabilizing the Spine
Industry experts provide insight on new technology and market forces driving innovation.
By Michael Barbella


Packaging & Sterilization Firms Respond to Customers' Demands
Orthopedic OEMs want products that are sturdier, lighter, safer and faster.
By Mark Crawford


A Manufacturing Partnership With a Backbone
Product realization success can involve business and technical partnerships.
By Susan Mucha, Powell-Mucha Consulting, Inc.


Coping With Change
Medical device regulatory experts provide perspectives of what might take place under the new FDA leadership.
By Allison Weaver


A Changing Landscape
Speakers hit a variety of industry hot topics at this year's fourth annual event.
By ODT Staff Report


Editor's Letter
Don't Tread on Us


News Front
Stryker Biotech Indicted by U.S. Attorney’s Office


Reimbursement Roadmap
Process Provides Opportunity to Improve Physician Payments
By Tim Hunter, MCRA, LLC


Clinical Trials
An industry software expert provides proven technology strategies for medical device manufacturers.
By Dr. Satish Tadikonda, Virtify


Process Improvement
Supply Chain Management: It’s Just Good Business
By Joe Condon, Plante & Moran PLLC


Financial Reports
Innovation, Demand Help Medtech Industry Survive Recession


Market Snapshot
Spinal Implant Market Grew 9% in '08


Industry News
FDA Requires Postmarket Studies for Spine Stabilization Devices


People News
Ascension Orthopedics Appoints Guy Mayer as CEO



September 2009


Mad About Metals
Innovation has broadened the use and biocompatibility of metal implants.
By Michael Barbella


The Quest for Quality
Good quality systems can help medical device firms boost productivity and profit.
By Michael Barbella


Orthopedic Opportunity
Business, engineering tracks offer robust lineup at fourth annual orthopedic event.


Materials Management
Accelerating Orthopedic Device Innovation
By Raymond Sirochman, ASM International


Wear Particles Affect Implant Success, Failure
Wear debris creates concern about longevity of implants; FDA has strict requirements.
By Dr. Janet Cotton and Simon Demnitz


Process Improvement
Learning From a Legend
By Joe Condon, Plante & Moran, PLLC


Editor's Letter
Move to Modernize


News Front
Schultz, Head of CDRH, Resigns Amid Controversy


Reimbursement Roadmap
The Health Insurance Debate Continues
By Charles E. Schneider, Schneider Musculoskeletal Clinical Regulatory Advisers LLC


Best Practices
Optimizing Business Value
By Bruce E. Jacobs


Financial Reports
Orthofix Achieves Record Revenue in Second Quarter


Industry News
PearlDiver and MCRA Form Patient Data Analysis Alliance


People News
Active Implants Corporation



July 2009


Top Companies Report
Still on Target: Our annual in-depth profiles of the top 10 players in the orthopedic device market..
By ODT Staff


Machining, Tooling Get More Cutting Edge to Meet Demand
Manufacturers review how to provide more value-added programs for their customers.
By Mark Crawford


Successfully Managing Change With Quality Management
Quality must be at the forefront of manufacturing & included in the product life cycle.
By Brenda Percy


Lean Principles: Lessons Learned
How one firm’s experience has allowed it to eliminate hidden costs through a focus on Lean.
By François Beaufrère


Editor's Letter
Equal to the Task
By Christopher Delporte


News Front
New FDA Chief Plans to Streamline Device Review


Reimbursement Roadmap
CMS Proposed 2010 Medicare Rule: Impact on Orthopedics
By Tim Hunter, MCRA LLC


Financial Reports
“Unfavorable Factors” Lead to Q1 Sales Descent at DJO


Market Snapshot
Small-Joint Implants Market Will Hit $1.8 Billion in 2015


Industry News
Smith & Nephew Realigns Operations to Lower Costs


People News
Symmetry Medical Board Selects Reynolds as Chairman


Risk Management
Regulatory Concerns Grow Over Outsourcing
By Marc Miller


Stryker Corp.
$6.7 Billion


DePuy
$5 Billion


Zimmer Holdings
$4.1 Billion


Smith & Nephew
$3.8 Billion


Synthes
$3.2 Billion



Biomet
$2.4 Billion


DJO Inc.
$980 Million



Wright Medical
$465 Million



May 2009


Demand for Implants Still Going Strong
Non-fusion technologies, ceramics, orthobiologics expected to drive growth.
By Michael Barbella


Choosing a Coating
The right surface modification technique brings benefits to patients with implants.
By Erik Swain


Trauma Trends
An industry analyst and orthopedic surgeon provide insight into market forces.
By Christopher Delporte


Regulatory Viewpoint
New Mass. Rules May Require Upgrade to Existing Systems
By Mark Langdon and Meenakshi Datta


Joint Reconstruction in Review
Orthopedic companies look to mix cutting-edge devices with cost-effective results.
By Christopher Delporte


Editor's Letter
Pricing Pressures
By Christopher Delporte


News Front
Senate Confirms Sebelius as Secretary of HHS


Reimbursement Roadmap
Medicare Proposed 2010 Rule: Impact on Orthopedics
By Jeffrey D. Zigler


Technology Trends
Cervical Interbody Device Eliminates Need for Plate; Occipitocervical Module Offers Spinal Fusion Options


Industry News
Orthofix Shareholders Reject Alternative Board Members


People News
Orthovita Names New Chairman; Fitzgerald Takes ArthroCare Post



March 2009


Innovation's Promise
Orthopedic firms understand the critical importance of the pediatric sector, but innovation has been slow to meet the needs of patients and physicians.
By Christopher Delporte


Material World
Advances in polymers and ceramics have improved the durability of implants.
By Michael Barbella


The PEEK of Large Joint Performance?
New PEEK yields lower wear and reduced immunological reaction for knee bearings.
By Amy Kinbrum


Memphis Mingle
Industry leaders to discuss orthopedic manufacturing’s future at first ODT Forum.
By Michael Barbella


OEMs Expect Suppliers to Stay Ahead of the R&D Curve
Spending time in operating rooms watching surgeons is key for design engineers.
By Mark Crawford


Editor's Letter
Change and more change.
By Christopher Delporte


News Front
Orthopedic surgeon shortage on the way, report says.
By Christopher Delporte


Regulatory Viewpoint
Revised AdvaMed ethics code contains significant changes.
By Mark Langdon


Risk Management
Post-Riegel: Device safety and risk management
By Kevin M. Quinley


Reimbursement Roadmap
Congress introduces plethora of healthcare proposals.
By Charles E. Schneider


Financial Reports
Wright Medical lowers ’09 guidance despite ’08 profit.
By Michael Barbella


People News
Osteotech is expanding its senior management team.
By Tim Sohn


Industry News
NuVasive invests in Dutch biotech firm.
By Michael Barbella



January 2009


Instruments Evolve
More thought is going into how orthopedic surgical instrumentation is designed, tested.
By Erik Swain


Biological Safety
Hazards of new medical devices must be studied so the risks are clear.
By David Parente


Shedding Suppliers
OEMs rethink the number of suppliers they use amid increasing federal scrutiny.
By Michael Barbella


Scrubbing in for Good Design
Operating room observations are key to innovative implant, device design.
By Jeffrey Kapec


Editor's Letter
Will Congress make retooling the FDA a priority?
By Christopher Delporte


Reimbursement Roadmap
With Obama, focus on comparitive effectiveness.
By Tim Hunter


Regulatory Viewpoint
The revised Sunshine Act emphasizes transparency.
By Mark Langdon


Risk Management
Medical device case: Federal versus state power.
By Kevin M. Quinley




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