Insights That

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What Happens After Clinical Trial Close-Out: Transitioning to Reimbursement
Clinical Research, Reimbursement Strategy, Regulatory Strategy, Market Access, CRO Services Crystal Norwood Clinical Research, Reimbursement Strategy, Regulatory Strategy, Market Access, CRO Services Crystal Norwood

What Happens After Clinical Trial Close-Out: Transitioning to Reimbursement

Clinical trial close-out is no longer the end of the development process. In 2026, sponsors must transition quickly from regulatory evidence generation to reimbursement and market access planning. Learn how clinical strategy, real-world evidence, payer expectations, and post-market planning now shape commercialization success for medical devices and combination products.

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Large vs. Boutique CRO: Which Is Right For Your Clinical Trial?
Clinical Research, Regulatory Strategy, CRO Services, Medical Device Development Crystal Norwood Clinical Research, Regulatory Strategy, CRO Services, Medical Device Development Crystal Norwood

Large vs. Boutique CRO: Which Is Right For Your Clinical Trial?

Choosing between a large CRO and a boutique CRO can significantly impact clinical trial timelines, budgets, and outcomes. This article explores the strengths and limitations of each model, outlines key questions sponsors should ask during vendor selection, and explains why many medical device and combination product companies benefit from a more specialized, hands-on CRO partnership.

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The FDA’s QMSR Is Now in Effect
Regulatory Strategy, Quality Systems, FDA Compliance, Risk Management, Medical Device Development Crystal Norwood Regulatory Strategy, Quality Systems, FDA Compliance, Risk Management, Medical Device Development Crystal Norwood

The FDA’s QMSR Is Now in Effect

The FDA’s Quality Management System Regulation (QMSR) is now in effect, aligning U.S. medical device quality requirements with ISO 13485. Learn what’s changed, how FDA inspections are evolving, and how manufacturers can implement defensible risk management approaches—without being locked into ISO 14971.

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The Sales Trap That’s Costing You Clients
Regulatory Strategy, Industry Commentary, Podcast Features, Business & Growth, Consulting & Advisory, Client Relationships, Clinical & Quality Integration Crystal Norwood Regulatory Strategy, Industry Commentary, Podcast Features, Business & Growth, Consulting & Advisory, Client Relationships, Clinical & Quality Integration Crystal Norwood

The Sales Trap That’s Costing You Clients

In this Q&A recap of The Business of Learning Podcast, NMCG President & Principal Consultant Michael Nilo joins host João Camargo to unpack the “sales trap” that costs expert service providers clients: stopping at “you can’t do that” instead of mapping what is possible. Learn how NMCG blends regulatory rigor with practical, business-savvy guidance for medtech innovators.

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Navigating the FDA During a Government Shutdown
Regulatory Strategy, FDA Insights, Risk Mitigation, Industry Commentary, Podcast Features Crystal Norwood Regulatory Strategy, FDA Insights, Risk Mitigation, Industry Commentary, Podcast Features Crystal Norwood

Navigating the FDA During a Government Shutdown

When the U.S. government shuts down, FDA operations slow—and medical device companies can face costly delays. In this Global Medical Device Podcast Q&A, NMCG President and former FDA Scientific Reviewer Michael Nilo explains what continues, what stops, and how MedTech leaders can strategically navigate the disruption.

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