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From r/prediabetes: “I just started wearing a CGM and now I can’t stop reading about plasticizers in the adhesive. Is this actually something I should worry about, or is it just internet noise? Genuinely don’t know who to trust here.”  That thread has over 400 comments. Some are reasonable. Some are not. A lot of them cite studies nobody actually linked, or repeat a claim that started somewhere else and got passed along until it sounded like fact.  This is a real concern with a confusing answer, and most of what’s online doesn’t actually explain how CGM materials get evaluated before they reach a patient’s arm.

From r/medicaldevices: “Our R&D team thinks design controls are bureaucratic box-ticking. Our regulatory lead says we’re building something we can’t submit. They’re in the same room and they’re not speaking the same language. Has anyone actually fixed this?” 

From r/medicaldevices: “We have OEKO-TEX STANDARD 100 certification on all our textile components. Our investor keeps asking if that’s ‘good enough’ for FDA. Honestly — I don’t know what to tell them.”  If you’re a founder or an investor in the medical device space, this scenario probably feels familiar. You’ve spent real money getting your textile materials certified. The certificate looks official. It has logos, test numbers, a clean layout. It says the materials are safe.

Silent Killers of 510(k) Submissions: Biocompatibility Report Gaps  By Kandih Bioscience  •  Regulatory Strategy Series  The truth is, it rarely comes out of nowhere. There are specific, well-documented gaps in […]