Viewpoints on Innovation

Beyond Compliance: Medical Device Product Development

Medical Device

Kalypso has spent the last several years exploring how leading medical device companies - from startups to multibillion dollar enterprises - are balancing new product development with compliance requirements. Finding the right balance between what can seem like competing objectives, and understanding how leading companies are doing so, is the focus of this paper.

Originally published on March 10th, 2010

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Topics: Beyond Compliance, Compliance, Decision Making, FDA, FDA Compliance, FDA Regulations, Innovation, Life Sciences, Life Sciences Consulting, Life Sciences Innovation Consulting, Medical Device, Noel Sobelman, Perspective, Product Development, Project Governance

About the Author

Noel Sobelman

Noel Sobelman

For the past 25 years Noel has worked extensively in the areas of innovation strategy, product development, portfolio management, product commercialization, and the software systems that enable innovation. His industry background includes experience with high technology, life sciences, consumer packaged goods, industrial, and renewable energy companies. He is a frequent speaker, researcher, and writer on innovation effectiveness, disruptive innovation, and time-to-market reduction. 
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