Bridging of Technologies: Union of Pharmaceutical and Medical Device Industries Brings Opportunities

Pharmaceutical and medical device companies are finding innovative means to deliver multifunctional healthcare products through converging technologies.

Keys to Offshore Outsourcing | Medical Device Makers Starting to Look for Overseas Partners

Like companies across many industries, medical device manufacturers are increasingly turning to international partnerships to find ways to exploit the efficiencies that outsourcing offers. These companies are finding that successful and efficient outsourcing allows them to allocate internal resources to projects more strategically and prioritize tasks in their product pipelines.

Open Up But Stay Focused

In today's explosive medical devices industry ($75 billion in the U.S.), the benefits offered by successful outsourcing and co-development are reaching a plateau that is simply hard to overlook.

Emerging Rapidly

As a result of technological advances and increased understanding of central nervous system, neurotechnology has become one of the fastest-growing emerging technologies.

Nerac Analyst Marco Bafan Published in Medical Design Technology - May 08

Nerac Analyst Marco Bafan shares his insight with the readers of the May 2008 issue of Medical Design Technology in a “Perspectives” feature titled “First Step in Design.” Click here to read the article.

Nerac Analyst Marco Bafan Quoted in Pharmaceutical Commerce Magazine - April 08

Nerac Analyst Marco Bafan talks about the regulatory environment affecting combination medical device-pharmaceutical products in this April 30, 2008 article in Pharmaceutical Magazine. Click here to read the article.

Nerac Analysts Deb Schenberger & Marco Bafan Published in Med Tech Precision Magazine - March 08

In an article titled, “Bioceramics: The Future of Joint Healing,” Deb Schenberger and Marco Bafan examine trends in technology that could make joints stronger and that are less likely to require replacement surgeries later. Click here to read the article.

Next-Generation Combination Products Is Topic for Nerac Analysts In MX Magazine

Nerac Analysts Marco Bafan, Jeffrey Prsha and Deborah Schenberger write that technology convergence and corporate collaboration are propelling rapid changes in today’s medical device market. Read more

Revised EU Medical Device Directive Needs Immediate Attention

Medical device manufacturers should start initiating strategies now to comply with the new requirements of the amended European Union Medical Device Directive that take effect in March 2010. Read more.

Nerac Analysts Marco Bafan and Deb Schenberger present at OMTEC 2009

June 24-25, 2009 — Rosemont, Illinois

Nerac Analyst Marco Bafan will be presenting "Keys to Offshoring/Outsourcing" and Nerac Analyst Deb Schenberger, Ph.D., will present “Clinical Literature Reviews and Regulatory Changes in Europe.”

Read more.

Nerac Analyst Marco Bafan published in Summer 2009 issue of Orthoworld

Outsourcing/Offshoring Trends in the Orthopaedic Industry

With rapid growth of an aging population and the growing epidemic of obesity, along with technological advances, orthopaedic companies must continually develop innovative products to gain market share and ultimately, to maintain a competitive edge in this growing market. Read more.

Nerac Analyst Marco Bafan to speak at IMPLANTS: The 6th International Outsourcing and Solutions for Orthopaedic Implants and Biomaterials Conference and Exposition

Marco Bafan will speak on medical device reimbursement at the IMPLANTS Conference held May 27-28, 2010 in Lyon France.  To learn more, click here.

Clinical Literature Reviews | Changes in EU Medical Device Directive Require Immediate Steps

Nerac white paper urges medical device manufacturers to take immediate steps to deal with changes that could affect their access to the EU market.

Obtaining CE Mark Certification using Clinical Literature Reviews

The European Market for Medical Devices is estimated at over $86 billion, with expected annual growth of at least 5% over the next several years.    In order for medical devices to be approved for sale in the European Union member countries they must be certified with a CE mark, which indicates conformity to the Medical Device Directive 93/42/EEC and other applicable industry standards.  

A new revision of the directive, MedDev 2.7.1 Rev 3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” was released in December 2009, and supplements the original requirements by offering specific requirements and guidelines for medical device manufacturers to demonstrate the safety and efficacy of devices through a review and analysis of clinical performance data.

It is imperative for medical device manufacturers to achieve and maintain compliance with this guideline as part of the CE Mark certification process. At stake is maintaining or increasing share in the growing $86 billion European market that accounts for a significant percentage of most U.S. medical device manufacturers profits.

This white paper examines the use of clinical literature data as an acceptable and practical alternative to clinical trials, not only for new product introductions, but also for previously CE-marked devices which have been on the market for several years. 

Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond

Market Overview: Orthopedic Implant Players and Products

This overview of the orthopedic implant coating technology market is an example of a Nerac Expert Research Request report.

Market Assessment: Orthopedic Implants

This assessment of the orthopedic implant market is an example of a Nerac  Research and Advisory Services request report.