profile

The Capability Edge

A monthly note on design quality and regulatory practice for medical device teams

John Salvato, Ph.D., Founder & President — Design Quality Services DQS helps medical device teams move beyond compliance and build real capability — stronger designs, fewer rework cycles, better submission outcomes. Recognized as a Top Medical Device Consulting firm by MedTech Business Review, 2026. Knowledge is the shortest path between ingenuity and impact.

PostsRecommendations
The Capability Edge, October 2026 — what makes design reviews work
Featured Post

Medical Device Design Reviews: Structure, Pace, Opportunity

THE CAPABILITY EDGE — OCT 2026 Structure, pace, and opportunity — What thirty years of design reviews and one software paper agree on A paper has been sitting on my desk for a few weeks, written by Kemerer and Paulk (IEEE Transactions on Software Engineering, 2009), about a large study of what makes technical reviews effective. They concluded that well-structured, well-paced code reviews found substantially more defects than unstructured, poorly paced reviews. The authors stated the...

3 days ago • 5 min read

The Capability Edge — September 2026 The Cost of Training Is Visible. The Cost of Insufficient Capability Often Is Not. When organizations begin tightening budgets, professional development is frequently treated as a discretionary expense. The reasoning is understandable: training has a visible and immediate cost, while its financial return can be difficult to isolate. In medical device development, however, that framing is incomplete. The more useful economic question is not simply what it...

about 1 month ago • 3 min read
The Capability Edge — design quality newsletter from Design Quality Services.

Why Quality Problems Keep Repeating in Medical Device Organizations Every medical device organization wants to produce safe, effective products while satisfying increasingly rigorous regulatory expectations. Yet many companies continue to experience the same quality problems repeatedly. CAPAs recur. Design reviews uncover familiar deficiencies. FDA observations identify issues that leadership believed had already been resolved. Despite extensive procedures, documented quality systems, and...

about 1 month ago • 2 min read