Insights That

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Helping you make smarter decisions, avoid costly missteps, and
bring safe, effective products to market with confidence

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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Trying to Keep Up in April
Regulatory Strategy, Clinical Research, MedTech Insights, Trying to Keep Up Crystal Norwood Regulatory Strategy, Clinical Research, MedTech Insights, Trying to Keep Up Crystal Norwood

Trying to Keep Up in April

April’s Trying to Keep Up episodes covered FDA shifts, clinical strategy decisions, and the realities of working in MedTech right now. This recap breaks down the key takeaways, what they mean for your team, and includes a full roundup of the podcast’s now-signature intro jokes.

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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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How a Government Shutdown Affects FDA Medical Device Regulation
Regulatory Strategy, FDA Submissions, Medical Device Submissions, Policy & Compliance Michael Nilo Regulatory Strategy, FDA Submissions, Medical Device Submissions, Policy & Compliance Michael Nilo

How a Government Shutdown Affects FDA Medical Device Regulation

Government shutdowns don’t completely stop the FDA—but they do create unpredictability. While essential functions like recalls and safety monitoring continue, new submissions, inspections, and policy development often stall. Learn what history tells us about shutdown impacts and how device makers can prepare.

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