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November/December 2009

Decision Time


In the second article from our two-part series, contract manufacturers and OEMs discuss the complicated thought process behind the decision to form outsourcing partnerships.


Michael Barbella



In Limbo


Medical device firms are plagued by uncertainty as healthcare reform plays out in Washington, D.C.


Jim Stommen



Coping With Change


Medical device regulatory experts provide their perspectives of what changes might take place under the new U.S. Food and Drug Administration leadership.


Allison Weaver



Clinical Trial Disclosure


An industry software expert provides proven technology strategies for medical device manufacturers.


Dr. Satish Tadikonda, Virtify



Integrated Approach to Supplier Quality Engineering


Through a strategic partnership with suppliers, companies can maximize efficiency and reduce the waste associated with outsourced products and processes.


Saleem Ganiy, Medtronic



Tips for Effectively Responding to a Form FDA-483 for Foreign Medical Device Manufacturers


Provide a detailed response plan, thorough documentation and translations.


Carolyne R. Hathaway Rebecca M. Schaefer, Latham & Watkins LLP; Seth A. Mailhot, Nixon Peabody LLP



MPO Symposium


OEMs, Suppliers Discuss Risk Management and the Value of Solid Partnerships


MPO Staff Report



October 2009

Pushing the Envelope


Tubing providers respond to medical device OEMs’ requests for smaller, thinner, uniquely shaped products.


Tim Sohn



Getting it Right


In the first article from our two-part series, contract manufacturing firms discuss the components to successful outsourcing relationships.


Michael Barbella



Room to Grow


Industry consultants report on emerging global markets that could be serious medtech players in the near future.


Evangeline Loh and Sage Farrar, Emergo Group



Outside Looking In


What foreign manufacturers need to know about the reach of U.S. courts.


Amir Ghavi, Lovells LLP



Show Preview: Medical Product Outsourcing Symposium


Industry experts will offer advice on minimizing risks and maximizing benefits.


The MPO Staff



2009 MPO Salary Survey


Medtech workers remain enthusiastic, though respondents report feeling the economy’s pinch more this year.


Christopher Delporte, Group Editor



September 2009

Online Exclusive: People News


Covington Associates, Pulmonx Corp., CleveX, Westlake Plastics Company, KCI make executive appointments.



Embarking on a Fantastic Voyage


Technology has made it possible for medical robots to evolve from the pages of science fiction novels to operating rooms.


Michael Barbella



The Time is Now


Executives say the upfront investment in automation is well worth it in the long term.


Tim Sohn



Meeting the Challenges of Lean Flow


An industry consultant provides guidance on implementing a basic Lean plan.


David McPhetrige, FlowVision LLC



Lean Principles: Lessons Learned


How one firm’s experience has allowed it to eliminate hidden costs through a focus on Lean.


François Beaufrère



What Every Foreign Medical Device Manufacturer and Importer Should Know


A review of medical device warning letters issued to foreign manufacturers by the FDA, 1997-2007, Part II


Carolyne Hathaway, John R. Manthei and Seth Mailhot, Latham & Watkins LLP



July/August 2009

Top Companies Report


Still On Target: Our annual roundup of top 30 medical device companies reveals that the industry has done a good job of weathering a perfect financial storm.


The MPO Staff



Faster, Leaner, Cheaper


Medical device companies are relying on prototyping to satisfy or exceed client expectations.


Mark Crawford



The Electronic Slide


Even in a global recession, medical device customers want custom “one-stop shopping” solutions, new technology.


Tim Sohn



Managing the Total Product Life Cycle


The changing face of medical device product development.


Daniel R. Matlis, President, Axendia Inc., and David Rubin, Director, Vertical Market Strategy Medical Devices, PTC



What Every Foreign OEM, Importer Should Know


A review of medical device warning letters issued to foreign manufacturers by the FDA, 1997-2007.


Carolyne Hathaway, John R. Manthei and Seth Mailhot, Latham & Watkins LLP



June 2009

Online Exclusive: 2009 BIO International Convention


Feeding, Fueling and Healing the World Through Innovation


Michael Barbella



Molding Matters


Molding providers are adjusting to shifting economic and market demands to offer their medical device customers a more complete-and secure-set of services.


Christopher Delporte



Web Exclusive: The Rest of the Story …


Molding experts weigh in on cost, quality, changing economics and healthcare reform.


Christopher Delporte



A Standard Challenge


A perpetual flow of revisions to sterilization and packaging standards reveals the only true constant in the industry: change.


Michael Barbella



Cardiovascular Device Industry Keeps Beating


Recession doesn’t stop pacemaker, defibrillator and stent breakthroughs, and triggers increased outsourcing by OEMs.


Tim Sohn



Living the Map


College graduate's quest to work 50 jobs in 50 states leads him to a medical device manufacturing plant in Minnesota.


Michael Barbella



May 2009

Charting the Course of
Full-Service Outsourcing


Industry experts remain bullish about market growth for medical device outsourcing, though current economic realities create a new set of challenges.


Christopher Delporte



The Quest for Quality


Good quality systems can help medical device firms increase their productivity and profit.


Michael Barbella



Offshoring in an Off Economy


Some medical device manufacturers are continuing with expansion projects already under way in Latin America, while others are delaying projects until the markets see signs of improvement.


Tim Sohn



Looking East for R&D and Clinical Trials


R&D in Asia has the potential to significantly improve the global performance of medical device companies by cutting costs and speeding product development, but extensive due diligence is required for success.


Ames Gross and John Minot



April 2009

Raw Possibilities


Stabilized prices and industry consolidation are creating a wealth of opportunities for raw materials suppliers and contract manufacturers.


Michael Barbella



Embracing Change, Seizing Opportunity


In the face of market uncertainty, Tony Mulone, head of Covidien’s Custom Product Solutions division, sees opportunity—for his company and for industry.


Christopher Delporte



Slow Motion


Interoperability is gradually making progress, but a catalyst is needed to pick up the speed.


Tim Sohn



Software Opens New Frontier of Quality


Device companies must have the right software in place to prevent issues with quality.


Erik Swain



Want to Outsource Your Supply Chain?


Defining business requirements and performance benchmarks can help ensure success.


Marc Tanowitz and J.P. Baritugo



March 2009

Tubing Designs Bring Extrusion Challenges


Medical tubing designs are getting more complex, which has led some companies to rethink their extrusion processes.


Erik Swain



The Ultimate Test


Companies that provide testing services to OEMs and other device manufacturers are testing the waters in new markets in order to stay competitive.


Michael Barbella



Industry Q&A: Outsourcing vs. Offshoring


A group of industry insiders shares thoughts on the definition of outsourcing, where the overlaps are, misperceptions and ways medical device companies distinguish between the two.


Christopher Delporte



Lessons Learned in Globally Supporting High-Mix, Variable-Demand Projects


Device manufacturers face cost challenges with offshore outsourcing.


Chris Thyen



January/February 2009

Online Exclusive: An In-depth Q&A with Costa Rica's Minister of Foreign Trade


Sign up now for MPO's first-ever international symposium.



Taking the Lead in R&D


Device firms that outsource research and development are better equipped to focus on their core competencies, which ultimately leads to improved efficiency.


Michael Barbella



Charging Forward


Even in a down economy, electronic manufacturing services firms remain positive about the bottom line.


Christopher Delporte



Keeping Up With Demand


The adaptive, high-tech world of machining and laser processing continues to innovate.


Mark Crawford



Non-Traditional Solutions


Yulex and TechDevice partner to provide allergy-resistant catheter technology.


Christopher Delporte



ASEAN Medical Device Regulatory Integration


Countries working to modernize the healthcare industry may easy device entry into Southeast Asia market.


Ames Gross and John Minot



Destination: Costa Rica


Industry leaders will tackle international manufacturing issues at the first international MPO Symposium.


MPO Staff Report



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