Solid Culture Can Help Avoid Development Hurdles

CONFERENCE NEWS: MD&M WEST

Inevitably, roadblocks will be thrown up during a medical device product development process. But there are ways to get around them if you have the right attitudes and procedures in place, two experts told a Medical Design & Manufacturing (MD&M) West conference session audience.

Bill Evans, president of Bridge Design (San Francisco), and David Maltz, product development professional for Nektar Therapeutics (San Carlos, CA), said that firms often unwittingly put up barriers to innovation.

The roadblocks, Evans said, come primarily in three categories: product definition, resources, and culture. (However, he added, regulatory issues can also put up roadblocks, but device companies do not have much control over those.)

He said that product definition means a firm's ability to pinpoint the focus of a product based on trends in a particular therapy as well as on industry trends and customer needs. “Companies that push customer contact deep down are the ones that are successful and produce better products,” he said. “They have a deeper understanding of qualitative and quantitative market inputs.”

Maltz said Nektar has developed standard operating procedures that encourage accurate product definition. “It has to come from senior management,” he said.

Resource issues are not limited to the amount of money available for product development, explained Evans. “Sometimes problems are created by planning driven by external events, not internal resource practicality. Sometimes management panics and shortcuts the R&D process, often to meet an artificial deadline such as a trade show.”

A firm's culture can impede product development when it is either too risk-averse or not diverse enough, Evans said. “Product development has a lot to do with failure. Large companies tend to hire top students and MBA holders who have not had to deal with failure,” he said. “That can make a company afraid to try new things and to communicate poorly internally.”

Copyright ©2007 Medical Device & Diagnostic Industry