PharmaMedDevice Industry Blog

First International Study of Paclitaxel-coated Stent for Use Outside the Heart

Cook Medical recently announced that the first US patients involved in a Phase II clinical trial of the Zilver PTX Stent were treated at Tri-City Medical Center in Oceanside, CA.   The Trial is taking place at 28 US locations and represents the first medical device trial conducted simultaneously in the US and Japan.   Based on clinical data results collected, Cook Medical will be seeking regulatory approval in both markets.   This stent is intended to treat peripheral arterial disease (PAD), which affects more than 10 million Americans each year. Stent implementation is an exciting option because patients can often avoid surgery and get back on their feet much more quickly after having a stent implanted.  It will be interesting to see if the same drug-eluting technology found in cardiovascular stents can be used to treat blockages in arteries outside of the heart – or if any of the long-term clotting concerns will be raised with these products as they have with the cardiovascular stents. 

Combination Products Whitepaper

A newly announced white paper, "Combination Products: Navigating Two FDA Quality Systems," authored by Microtest Laboratories Inc's President and Chief Scientific Officer, Steven Richter, Ph.D, points out some of the challenges that manufacturers are facing when developing combination products. Many of you probably caught Richter's presentation "The Challenges of Testing Combination Products" at PharmaMedDevice this past April.

This paper is a great validation for many in the industry as it states that the FDA received 275 combo product submissions in 2005, and an estimated 30% of new products under development today are combo products.  It also reinforces that these innovative combination products bring a host of regulatory challenges and questions for manufacturers – related to testing guidelines, practices, and regulations unique to these products – and how manufacturers need to ensure that quality systems are in place and compliant with FDA regulatory requirements. This six page white paper is available for free download at http://www.microtestlabs.com/combinationpaper. Enjoy!

The Promise of Personalized Medicine - Innovation and Collaboration

Converging Biotechnology, Nanotechnology and Information Technology - Leading the Charge for Personalized Medicine -- A recent article in the Houston Chronicle discussed healthcare trends of the future with a focus on how biomedical innovations are likely to impact the promise of personalized medicine. It explores the convergence of the biotechnology, nanotechnology and information technology fields and addresses the sizable future markets for pharmaceuticals and medical devices made possible by these three converging technologies. Personalized medicine should not be considered a new business model, but rather a revolutionary combination of scientific breakthroughs resulting from collaborative life science research. As a patient, the promise of personalized medicine remains a highly attractive option. It introduces the concept of a personalized dose and treatment schedule based on one’s specific genetic and physical information. Customized medicines will essentially take out the guess work of treating patients and enhance patient outcomes.
And it is estimated that the demand for nanotechnology medical products will grow by more than 17% annually to reach $53 billion in 2011.*

It appears as though innovation and collaboration are becoming synonymous terms!

CT is a medical device hotbed

The medical-devices market in the U.S. totaled nearly $86 billion in 2006 - and almost $220 billion worldwide. Such statistics bode well for the Connecticut medical device market, which Bronzino (Mr. Joseph Bronzino Ph.D., P.E Executive Director - BEACON) says is thriving. In a 2004 report (the most recent available) commissioned by Northeast Utilities, BEACON charted 304 medical-devices companies and medical-devices manufacturers situated along the I-91 corridor between New Haven and Springfield, Mass.  "Probably two-thirds are in Connecticut, and many continue to expand," says Bronzino. The survey also showed two out of three companies were medical-devices manufacturers.

"A lot of the precision manufacturing companies that served the aerospace and the defense industries have diversified," Bronzino explains. "With the reduction of those industries, they have been looking for other places to use their skills. The skill set for medical devices is a natural extension of their capabilities, and has made them more survivable." Over the past five or six years, Eastern Plastics Inc. of Bristol (CT), 

Peas in a podcast

"Truly innovative products can improve the effectiveness of medical therapies, help to achieve efficiencies, and thus become part of sustainable solutions to health care challenges. In particular, there are significant opportunities for companies to take advantage of an emerging trend—the convergence of pharmaceuticals and medical devices in combination products.  Often without the expertise to develop their own drugs, many medical device OEMs are looking for partnership and licensing opportunities with pharmaceutical companies or hiring pharma experts."

This is just a glimpse of the article titled, “Key Considerations for Developing Combination Products: Accelerate the Innovation of Combination Products to Reap First-to-Market Advantages” written by me - Christine Ford, Event Director, of PharmaMedDevice -- everyone in the industry should hear this... Enjoy!

Direct download: MP3
(This a large file, download time maybe long)

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Based on an article originally published in Healthcare Packaging, 2006; download the article here.

FOI- Oh Boy!

FOI Online is an interesting website being shared for those in need of FDA regulatory documents. FOI maintains a library of more than 150K FDA documents in all categories of products regulated by the agency, including combination products. Documents can be downloaded right away using FOI Online. There is no charge for the service, and you can call to check availability of what you are looking for at no charge, and they even offer a free document of the week. You can find an extensive list of more industry links here. Happy Searching!

PharmaMedDevice

WELCOME to PharmaMedDevice's Industry Alert is a web log (blog) edited by Christine Ford, Event Director of PharmaMedDevice - to support the converging industries that this event serves – medical device, biologics and pharmaceutical – as well as highlight exciting product and technology innovations happening in healthcare.