Design Quality Services: Building Capability in Support of Device Innovation

When Dr. John Salvato evaluates medical device design, he is rarely looking for missing documentation. The procedures are usually there. The artifacts are usually there. The design file is usually marked complete. The risks are usually deemed acceptable. But what he is looking for is harder to see. Did the development practices actually challenge the design? 

“Most quality problems aren’t compliance failures,” Salvato says. “They’re capability gaps. The artifacts were completed, but the thinking behind it wasn’t.” 

That distinction underpins Design Quality Services (DQS), the Kalamazoo-based consultancy Salvato founded in 2017 after decades of leading design, quality, and manufacturing teams. DQS works with device manufacturers on design controls, risk management, software development, usability engineering, and other topics. And increasingly, the training that makes those systems work, not just exist. 

What capability gaps cost 

DQS recently published a paper highlighting the problem. Design rework consumes an estimated 40 to 50 percent of development costs, and 70 to 85 percent of that rework traces back to poor requirements. In other words, teams do the work early but discover the problems late. McKinsey places the medical device industry’s cost of quality at 6.8 to 9.4 percent of sales, with $6 to $11 billion recoverable annually through better practice. 

FDA’s data shows roughly two-thirds of first-cycle 510(k) submissions draw an Additional Information request that stops the review. Each one is typically a design, testing, or rationale gap a better-prepared team would not have left. 

“The cheapest place to fix an error is before it is ever designed in,” Salvato says. “Competence shifts detection earlier in development. An engineer who understands what a robust design input looks like does not write the ambiguous requirement that later forces a redesign.” 

Capability, not compliance 

DQS focuses on small and mid-size companies where the design, quality, and regulatory personnel often wear several hats. These teams face the same FDA expectations as a multinational, often without the requisite expertise or even an opportunity to learn these crucial skills. 

That gap led to a self-paced training library alongside the consulting practice. Courses cover Design & Development, Safety Risk Management, Cybersecurity Risk Management, Usability Engineering, Design Validation, Process Validation, and FMEA, built around real cases from audits, submissions, and inspections rather than regulatory recitation. 

“There is a lot of compliance-focused training that just teaches the dry regulatory text,” Salvato says. “We provide capability-focused training. We understand the regulations, but we focus on implementing those regulations smartly.” 

A certified ISO 13485 Lead Auditor, Dr. Salvato holds credentials in ISO 14971, FDA design controls, cybersecurity risk management, IEC 62304, and others. 

Fundamentals in the age of AI 

At the Medical Device Summit, John joins the panel on AI in medical device product development. A topic he recently explored across two episodes of the Solabs Automating Quality podcast. 

His position isn't skeptical, but it is demanding. AI will generate a requirements trace, a hazard analysis, or an FMEA in seconds, and it will do so with equal confidence whether the underlying design is robust or not. 

“What used to be a slow, visible failure now happens fast and looks finished,” John says. “Teams getting real leverage from these tools are the ones whose development discipline was already sound. The teams without it are just generating documentation faster.” 

That argument, that the fundamentals matter more rather than less as AI tools accelerate development, is what he brings to the panel discussion on September 30. 

Learn more 

DQS publishes The Capability Edge, a monthly newsletter on design quality and regulatory practice for device teams, covering topics auditors flag, what AI changes about design discipline, and practical scorecards and checklists. Subscribe at https://design-quality-services.kit.com/capability-edge. 

Visit the DQS table at the Michigan Medical Device Summit or explore the training library at https://designqualityservices.thinkific.com.