How Do You Know Your Medical Device Material Will Pass Biocompatibility Testing? with Marina Daineko
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How Do You Know Your Medical Device Material Will Pass Biocompatibility Testing? with Marina Daineko
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"Is this material going to be biocompatible?" is one of the most commonly asked questions in medical device development.
The problem is, there's no such thing as a biocompatible material.
In this episode, I speak with Marina Daineko, Biocompatibility Consultant at Intrinsic Medical Group, about how biological risk assessment actually works, what mistakes companies make early in development, and how to incorporate biocompatibility thinking during prototyping without running full testing on every grade.
This conversation is technical, practical, and based on real consulting work. We talk about the ISO 10993-1 framework, extractables and leachables, CMR substances, and why a structured plastic selection process helps you mitigate biological risk before it becomes a costly problem.
If you work in MedTech and want to understand how to think about biocompatibility earlier in development, this episode will help you make better material decisions and avoid expensive surprises late in the process.
🔗 CONNECT WITH MARINA DAINEKO:
Intrinsic Medical Group: https://www.intrinsicmedicalgroup.com/
LinkedIn: https://www.linkedin.com/in/marinadaineko/
Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech materials and innovation
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📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch
#GradicalPodcast #MedTech #MedicalDevices #Sustainability #Biocompatibility #Plastics #ISO10993 #MaterialSelection
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