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November/December 2010

The ‘New Normal’


Buffeted by the economy and regulatory overload, medtech companies adjust to life in the next decade.


Jim Stommen



Game Change


Device firms prepare for the unknown as the FDA gives its controversial 510(k) clearance process a much-needed facelift.


Michael Barbella



Setting the Benchmarking Bar


In the final installment of our two-part outsourcing best-practices series, OEMs and suppliers discuss how to continue to improve even the most efficient and effective collaborations.


Mark Crawford



Cautious Optimism Reigns


Medtech professionals report growth in the industry, but remain uncertain about what the future may hold.


Christopher Delporte



Learning Lean


A contract manufacturer gets introspective with a company-wide focus on the elimination of waste.


Thomas Ho



October 2010

More ... and Faster


Regulatory hurdles and the need to control costs is key for tubing suppliers in dealings with their customers.


Jim Stommen



The Partnership Treadmill


Establishing best practices in an outsourcing relationship is an ongoing process that keeps both sides running.


Mark Crawford



International Smorgasbord


Overseas operations have become an essential part of the device manufacturing and outsourcing process, but the move is not without risk.


Michael Barbella



Business Process Outsourcing: Finding the Right Vendor


Selecting the right vendor-partner is critical to medical device manufacturers’ success when outsourcing business processes.


David Borowski and Marc Tanowitz



The Partnership Puzzle


The fourth annual MPO Symposium returns to the Boston area with a formula for improved outsourcing strategies on the agenda.


MPO Staff Report



September 2010

The Automation Equation


Assembly and automation continue to play a key role in cost reduction and process improvement.


Mark Crawford



The Legacy of Lean


Doing more with less is no longer limited to the manufacturing process.


Michael Barbella



Early Planning, Future Reward


Proper product development involves taking proactive steps to avoid pitfalls that may come when potential risks are not adequately considered.


Erik Swain



Ensuring Efficient Recall Management


Determining where the quality management system fits into the process is key to mitigating risk.


Brenda Percy



Safeguarding Your IP


Use of the International Trade Commission’s “Section 337” can be a powerful tool to protect medical device firms’ intellectual property.


Gary M. Hnath



July/August 2010

The Top 30


A transformational year for the industry's largest firms.


Group Editor Christopher Delporte, Managing Editor Michael Barbella, and Contributing Writer Jim Stommen



Companies to Watch


A look at four growing medtech firms with the technology - and temerity - to play in the big leagues.


Jim Stommen



Prototyping and Production


Changing market conditions make prototyping and production a delicate balancing act


Mark Crawford



Making the Case for Outsourcing


How contract manufacturers offer optimal collaboration options to drive efficiencies and maximize ROI


Jeffrey Zajac



Technical Debt in Medical Software


Early intervention leads to longer product life


Dan O’Connor, Tim Bowe



June 2010

Modernizing Molding


Technological advancements to equipment and new ways of manufacturing tiny parts is keeping the molding industry on the cutting edge of innovation.


Michael Barbella



Last But Not Least


Packaging and sterilization are critical for compliance and speed to market.


Mark Crawford



An IP Primer


Knowing the basics of intellectual property and licensing issues in medical device outsourcing transactions can save significant headaches, time and money.


Atabak Royaee and Toby Kusmer



Lean Planning for Medical Devices: Part II


Having all the elements in place for efficient procurement will ensure the most effective Lean manufacturing processes.


Preston “Jay” McCreary



May 2010

Fulfilling the Vision for Full-Service Outsourcing


Despite continued cost pressures and increasing government scrutiny, industry experts predict robust growth for the medical device outsourcing sector.


Michael Barbella



Chasing Quality


Quality control must keep pace with an evolving regulatory world.


Mark Crawford



Lucrative Latin American Locales


Contract manufacturers, OEMs say proximity to the United States is top advantage to having manufacturing plants in Latin America.


Tim Sohn



Lean Planning for Medical Devices


Creating a "pull" instead of a "push" system can save time and money, and make your manufacturing much more efficient.


Preston "Jay" McCreary



Platform Perfection


IVD instrument development time can be reduced through the effective use of platform technology.


Bruce Sargeant, Dr. Andreas Faulstich and Brian Jarvis



April 2010

Tying It All Together


Advanced software solutions enhance every step of the manufacturing process from design to production.


Mark Crawford



Listening To Her Heart


Personal tragedy drives engineer to market a device that can detect coronary artery disease.


Michael Barbella, Managing Editor



Finding the Hidden Value of Existing Inventory


There’s no quick fix; a long-term effort yields significantly bigger rewards.


Kelly Lucenti, Millstone Medical



Cardio’s “Next Big Thing”


Industry experts reflect on coming out of a downturn, market trends, new technology and the impact of healthcare reform.


Jim Stommen



A New Decade of Supplier Quality


New challenges force firms to develop novel approaches to supply chain issues.


Gerard Pearce, SQA Services



March 2010

Extrusion Evolution


Extrusion customers want tighter tolerances, better performance and lower cost.


Mark Crawford



Put to the Test


Contract test laboratories adjust to requests for more device testing, details from the FDA.


Tim Sohn, Associate Editor



A Critical Look


Conducting a thorough evaluation of a supplier can help OEMs reduce risk and increase their competitive advantage in the marketplace.


Michael Barbella, Managing Editor



Perfecting Product Transfer


Lessons learned from successfully transitioning multinational projects.


Tom Ferris, Kimball Electronics Group



Partnerships That Last: Building a Best-in-Class Approved Supplier List


Top five factors for choosing suppliers include audits and clear communication.


Kelly Lucenti, Millstone Medical Outsourcing



January/February 2010

A New Charge


Demands for full-service offerings and growth opportunities in the home healthcare sector are changing the face of the electronic manufacturing services market.


Michael Barbella



An Evolving Role


Is machining in medical device manufacturing an advanced science or a dying art?


Mark Crawford



R&D and Design Landscape Shifts With Economy


Industry executives say large OEMs are increasingly outsourcing projects in the early stages.


Tim Sohn



Negotiating Medical Device Outsourcing Agreements


Understanding the strategies and pitfalls of manufacturing contracts can save time and frustration.


Christopher J. Donovan, Esq., McDermott Will & Emery



Finding the Right Formula


Singapore’s public-private partnership synergies help eliminate hidden outsourcing costs.


Susan Mucha, Powell-Mucha Consulting, Inc.



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