Lean Product Development for Medical Devices: Accelerating Innovation and Reducing Costs

by Jeremy Moore | Aug 15, 2024 | Product Development

Streamlining Medical Device Manufacturing with Lean Product DevelopmentWhat is Lean Product Development for Medical Devices?Origins of Lean MethodologyRelevance to Medical DevicesKey Principles of Lean Product Development for Medical DevicesValueValue Stream...

Choosing the Right Path: 510(k) vs De Novo Pathways for SaMD

by Jeremy Moore | Jul 19, 2024 | Software as a Medical Device, Compliance and Regulatory Guidance, Product Development

Unlocking Regulatory Success: 510(k) vs De Novo Pathways for SaMDUnderstanding the 510(k) PathwayDefinition and Background of the 510(k) Pathway:Requirements of the 510(k) Pathway:Process for the 510(k) Pathway:Advantages of the 510(k) Pathway:Limitations of the...

Why Do We Need Risk Management for Medical Devices: How Risk Management Can Add Value and Reduce Risk

by Jeremy Moore | Jul 12, 2024 | Product Development, Compliance and Regulatory Guidance

Why Risk Management is a Game-Changer for Medical DevicesUnderstanding Risk ManagementWhat is Risk Management for Medical Devices?Why is Risk Management Crucial in the Medical Device Industry?Key Components of Risk Management for Medical DevicesRisk Identification:...

How to Validate a Medical Device Idea: From Concept to Market-Ready Device

by Jeremy Moore | Jun 26, 2024 | Product Development

Bridging the Gap Between Ideas and RealityAssessing the Value of Your IdeaIdea Validation (or Invalidation): Is Your Concept Worth Pursuing?Market Research and AnalysisBroaden Your Audience:Utilize Online Platforms:Feasibility StudyRegulatory...

Doing it Right the First Time: The Cost of Remediation in Medical Device Development and the Benefits of Good Design Practices

by Jeremy Moore | May 22, 2024 | Product Development

An Introduction to Remediation in Medical Device DevelopmentUnderstanding Remediation in Medical Device DevelopmentWhy Remediation in Medical Device Development Matters:The Cost of Neglecting Good Design Practices in Medical Device DevelopmentRegulatory Impact:Risks...

Setting the Foundation of Well-Defined User Needs in Medical Device Development to Maximize ROI

by Jeremy Moore | May 8, 2024 | Product Development, US FDA Regulatory Requirements

The Nuances of Design Inputs and User Needs in Medical Device DevelopmentPeeling Back the Layers: Understanding User Needs in Medical Device DevelopmentCrafting Solutions Rooted in EmpathyMaximizing ROI: A Simple Paradigm Shift in Approaching Product...