New Michigan-based Medical Product Manufacturing Effort provides solutions for Innovators

May 22, 2013

The University of Michigan Pediatric Medical Device Consortium (M-PED) is launching a new medical product manufacturing video on Vimeo. This 28-minute video: “Innovative Pediatric Manufacturing: Strategies & Solutions – A Guide To Bringing Your Device To Market” features critical content on FDA manufacturing requirements for both pediatric and adult products. Two products being manufactured in the State of Michigan are featured.

Since late 2009, M-PED has been focused on increasing and accelerating the process of pediatric device innovation specifically targeting the needs of children. While the U.S. market for medical devices is estimated at more than $90 billion, the demand for pediatric devices is relatively small, creating little financial incentive for companies to invest in the space. Historically, many corporate marketing and manufacturing partners have hesitated to become involved in producing medical products targeting small or niche markets.

“We launched this video effort for several reasons,” says Lindsay E. Klee, Commercialization Director, M-PED and the U-M Medical Innovation Center. “First, we’re frequently approached by medical inventors who need and/or want guidance on prototyping or manufacturing their product. We wanted to have a baseline of product development guidance to offer to a wide, geographically-diverse audience.” Second, “we frequently collaborate with industry partners who value knowing a product has been adequately tested and developed in accordance with FDA regulations.”

The video highlights a variety of large and small Michigan-based manufacturers and industry partners who have united with M-PED to focus on advancement of pediatric medical devices.  

One manufacturing partner featured in the video is CEO, Nader Najafi from Ypsilanti, Michigan-based ISSYS. Nader rationalized his participation in pediatric medical device manufacturing stating, “My team is very passionate about doing something that makes a major impact on people’s lives. Having the opportunity to help is very exciting.   The impact [on a child] may last for fifty or sixty years.”

“Manufacturing in Michigan is alive and adaptive. Showcasing local passion and knowledge was important,” added Klee.

James Geiger, MD, Executive Director of the M-PED Consortium explained his hopes for the future of the Consortium: “We want to be able to advise pediatric device innovators about the potential manufacturing options for their innovation so they can choose the optimal design to meet both the needs of the child and the manufacturing process.  As their product develops, we will help them continually assess the best manufacturing process for their stage of development.”

“Innovative Pediatric Manufacturing: Strategies & Solutions – A Guide To Bringing Your Device To Market” is now available for viewing.

Intended use: product development guidance & strategy.
Intended audience: industry, academia, FDA, government, non-profits, independent inventors, pediatric healthcare advocates, and manufacturers.