Abusing Lean Methodologies

Lean-PrinciplesLean methodologies emerged in manufacturing and have now been applied to many business processes including innovation management (1). It is the latest “best practice” in manufacturing for process improvement alongside Six Sigma and Theory of Constraints (TOC). But if you are relying solely on the lean methodologies to provide a silver bullet for long term financial success, you are unfortunately fooling yourself. Continue reading

Understanding Risk in Medical Device New Product Development (NPD)

risk_managementNew product development (NPD) consists of workflow, decision and information flow across multiple functions in an organization. Managing and mitigating risk for each project and the entire portfolio of projects is an essential management activity during NPD. A company’s ability to understand and manage risk can mean the difference between financial success and disaster. In developing products for the medical device industry, meeting FDA requirements presents an additional risk factor not found in other industries. This article will address three important sources of risk in developing products for the medical device industry and suggestions on how to manage. There will also be an opportunity to register for an upcoming free webinar that will provide additional information. Continue reading