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If you are building or scaling a medical device, sterilization problems will catch up with you. Usually later in the process than you want.
In this episode, I speak with Manuel Grandy, Consultant and Managing Partner at SteriComp GmbH, about what sterilization actually means in practice and why so many teams underestimate it until regulators start asking uncomfortable questions.
We talk about ETO gas, gamma radiation, and why there is no universally “correct” sterilization method. The right choice depends on materials, device design, supply chain constraints, and how well you understand the science behind the standards.
Manuel explains why sterile does not mean clean, why following a standard word-for-word is sometimes not enough, and how small decisions like where you place a biological indicator can delay approval by months.
If you work in MedTech development, quality, regulatory, or manufacturing, this episode will help you avoid painful surprises and make better decisions much earlier.
Connect with Manuel Grandy:
LinkedIn: https://www.linkedin.com/in/sterilisation/
Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: [email protected]
#GradicalPodcast #MedTech #MedicalDevices #Sustainability
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comments help us improve the podcast and bring you relevant topics. Let’s form a better world with plastics!
If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.
You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube
Website: www.gradical.ch
By Lucas PianegondaIf you are building or scaling a medical device, sterilization problems will catch up with you. Usually later in the process than you want.
In this episode, I speak with Manuel Grandy, Consultant and Managing Partner at SteriComp GmbH, about what sterilization actually means in practice and why so many teams underestimate it until regulators start asking uncomfortable questions.
We talk about ETO gas, gamma radiation, and why there is no universally “correct” sterilization method. The right choice depends on materials, device design, supply chain constraints, and how well you understand the science behind the standards.
Manuel explains why sterile does not mean clean, why following a standard word-for-word is sometimes not enough, and how small decisions like where you place a biological indicator can delay approval by months.
If you work in MedTech development, quality, regulatory, or manufacturing, this episode will help you avoid painful surprises and make better decisions much earlier.
Connect with Manuel Grandy:
LinkedIn: https://www.linkedin.com/in/sterilisation/
Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: [email protected]
#GradicalPodcast #MedTech #MedicalDevices #Sustainability
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comments help us improve the podcast and bring you relevant topics. Let’s form a better world with plastics!
If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.
You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube
Website: www.gradical.ch