by Max Lerman | Jun 8, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Vendor Selection and Bridging Strategy How Upstream Vendor Decisions Shape Downstream Clinical, Regulatory, and Commercial Outcomes Executive...
by Bryan Bobo | May 13, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Consider a combination product program that has navigated early development successfully. Design inputs established, verification testing underway,...
by Max Lerman | May 4, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed A Preventable Pattern: Where Early Integration [of Toxicology and Device Development] Pays Off There’s a quiet pattern that shows up again and again...
by Bryan Bobo | Feb 11, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed In a recent review exercise, Swissmedic, the Swiss national health authority examined a small set of Notified Body Opinions (NBOps) submitted in...
by Bryan Bobo | Nov 7, 2025 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed The downstream cost of uncoordinated Use Risk Analysis “We already have someone doing the HF work.” It sounds like a sign of progress, but to...
