Why does it take so long to bring a medical device to market? And what can we actually do about it?

Spencer Jones is a serial entrepreneur and the founder of XO MedTech and MedTech Vendors. In this episode, he breaks down the real problems slowing innovation in medical technology and shares practical solutions that work.

This isn't about motivation. It's about the structural issues that make MedTech innovation slow, expensive, and isolating—and the systems that can fix them.

Inside this episode, you will learn:

✔ Why clinical innovators struggle to translate their ideas into manufacturable devices 

✔ How the "glue person" who connects clinical needs to engineering is rare and critical 

✔ Why most innovators should try to get their competitors to steal their ideas (seriously) 

✔ How lean development and rapid customer feedback prevent year-long mistakes 

✔ Why engineers should see surgical cases and clinicians should visit manufacturing facilities

✔ Where AI can save massive time in MedTech (hint: it's documentation) 

✔ Why most MedTech teams need better vendor selection frameworks

Spencer shares real examples from his experience taking devices from idea through FDA clearance, raising $10M in venture capital, and working across vascular access, laparoscopic surgery, and orthopedic devices.

If you want to move faster, work smarter, and stop burning time on preventable mistakes, this conversation will help.

If you're a MedTech company struggling to make your devices more sustainable, CLICK here: https://lucaspianegonda.clickfunnels.com/optin1756907952105

Connect with Spencer Jones:
XO MedTech: https://xomedtech.com/
LinkedIn: https://www.linkedin.com/in/medtech-innovation/

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]

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.

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.

Many companies say sustainability matters, but only a few treat it as part of their strategy. One of them is Ambu, a global MedTech company and the market leader in single-use endoscopy. In this episode, Casper Venbjerg Hansen, Senior Director, Sustainability, Public Affairs, Risk and Compliance at Ambu A/S, explains how sustainability guides their decisions and why Ambu committed to it early.

Casper walks through Ambu’s long history with sustainability, including why they redesigned their endoscopes in 2009 to make future recycling possible. He shares how sustainability became strategic in 2022 when hospitals began asking for better environmental performance.

We talk about single-use and reusable systems, the real footprint of reprocessing, and why raw materials drive a large part of emissions. Casper also explains how Ambu introduced bioplastics across all endoscope categories, how their takeback and recycling program works, and what it means to design for circularity from the start.

If you want a practical look at how sustainability becomes a business advantage, this episode gives you a clear introduction.

Connect with Casper Venbjerg Hansen:
LinkedIn: https://www.linkedin.com/in/casper-venbjerg-hansen-322853/

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.

Many organizations rely on LCAs (Life Cycle Assessments) to guide sustainability decisions, but the method is only as reliable as the data and assumptions used to build it. In this episode, Thomas Kägi, Member of the Board at Carbotech AG, explains how to structure an LCA so that the results reflect real environmental impact and not just guesses or incomplete boundaries.

Thomas describes how the functional unit sets the entire frame for an analysis, why the use phase can overshadow production in environmental impact, and how to work with supplier-specific data when it is available. He also breaks down when uncertainty matters, how to start with a screening LCA, and why rules such as ISO standards and EPDs are essential for making comparisons that are fair.

In this conversation, we cover:

• Why an LCA only makes sense when the underlying question is clear
• How system boundaries shape the outcome of a study
• Why the use phase can account for most of a product's impact
• How to work with databases and supplier-specific data
• When uncertainty in LCA data matters and when it does not
• How standards create comparability across different products

🎧 If you want a practical understanding of how environmental impact is measured and how to avoid common mistakes, this episode provides a grounded and straightforward guide.

Connect with Thomas Kägi:

LinkedIn: https://www.linkedin.com/in/thomas-k%C3%A4gi-262648a0/

Connect with us:

If you're a MedTech company evaluating commercialization risk or sustainability challenges, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 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]

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.

Hospitals review new devices through a process that is far more complex than most teams expect. In this episode, commercialization specialist Jim Surek explains how he evaluates medical technologies and the three-part funnel he uses to predict whether a product will find traction. Jim describes how clinical performance, economic outcomes, and strategic or operational effects shape hospital decisions and why progress in only one area is not enough.

In this conversation, we cover:

• Why clinical gains must connect to measurable economic value
• How Jim structures a commercialization assessment
• How hospitals view workflow changes and resource requirements
• How reimbursement shapes the path from prototype to adoption
• What separates market-changing ideas from incremental improvements

🎧 If you want to understand how hospitals make purchasing decisions and how to position your device for success, this episode is a focused and practical guide.

Connect with Jim Surek:
LinkedIn: https://www.linkedin.com/in/jimsurek

Connect with us:
If you're a MedTech company evaluating commercialization risk or sustainability challenges, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 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 #Sustainability #MedTech #MedicalDevices

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.

Every MedTech company wants to innovate faster, but most are slowed down by one thing they barely realize is consuming half their development time: technical documentation.

In this episode, Karl J. Larsson, co-founder of Aligned, explains how Word- and Excel-based documentation structures create massive inefficiencies, audit delays, and innovation bottlenecks, and how a lean, software-driven approach transforms both speed and confidence.

In this conversation, Karl and Lucas discuss:

• Why up to 50% of product development time is spent on documentation
• How inconsistent files create “audit anxiety” and costly review cycles
• The real impact of moving from documents to design controls
• How automation strengthens change control and accelerates market access
•  Why freeing engineers from paperwork fuels innovation and sustainability

🎧 If you’re tired of documentation slowing your R&D team down, this episode is your roadmap.

Connect with Karl J. Larsson:
Website: https://www.aligned.ch
LinkedIn: https://www.linkedin.com/in/karl-johan-larsson-bab4312/

Connect with us:
If you’re a MedTech company struggling with documentation or sustainability challenges, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, 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/

#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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.

Marcel Kunz, Head of Packaging at Straumann Group, has spent his career making dental implant packaging safe, sterile, and sustainable.

In this episode, he joins Lucas Pianegonda to share Straumann’s six “Golden Rules” for designing medical packaging that balances compliance with circularity — plus the story behind his toothbrush project that turned blister waste into a useful consumer product.

• They cover:
•  The real cost of sterile barrier systems in MedTech
•  Why Straumann won’t wait until 2034 to adapt to PPWR
•  How a recycling experiment became a proof of concept for innovation
•  How sustainability connects patient safety with long-term impact

If you work in medical packaging or device design, this episode will change how you think about “waste.”

Connect with Marcel:

https://ch.linkedin.com/in/marcel-kunz-4250b373

Connect with Straumann:
https://www.straumann.com/group/us/en/home.html

Connect with us:

If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, 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

📺Watch these episodes on YouTube: https://www.youtube.com/@GradicalGmbH

🌍 Learn more about Gradical: https://gradical.ch/

📩 Work with Lucas and the team: [email protected]

#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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.

When Thomas Willemsen became CEO of GaleMed Group, he saw an opportunity to redefine medical consumables for a sustainable future. In partnership with Gradical, his team created the BioVent-Circuit — the world’s first anesthesia and ventilation circuit made from sugarcane-based bioplastic.

In this conversation, Thomas and Lucas Pianegonda discuss:
 • How GaleMed turned a concept into a validated, high-performing product
 • Why sustainability is a strategic advantage, not a cost burden
 • The challenges of market adoption in Europe and the U.S.
 • How Gradical helped bridge regulatory and materials expertise
 • What it takes to build category leadership in eco-consumables

📍 See the BioVent-Circuit at the GaleMed booth Hall 11/C51 during the Medica Fair in Düsseldorf, starting November 17

Connect with Thomas Willemsen:
LinkedIn: https://tw.linkedin.com/in/thomas-willemsen-32696b21

Connect with GaleMed: https://www.galemed.com/en

Connect with us:

If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, 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

📺Watch these episodes on YouTube: https://www.youtube.com/@GradicalGmbH

🌍 Learn more about Gradical: https://gradical.ch/

📩 Work with Lucas and the team: [email protected]

#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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.

Industrial design engineer Pablo Yániz González, who recently graduated in Integrated Product Design at TU Delft's Faculty of Industrial Design Engineering, set out to make a single-use inflator more sustainable and ended up designing a hybrid device that can be reused up to 1,000 times.

In this episode, Pablo joins Lucas Pianegonda to discuss how hospitals can reduce waste without adding burden for clinicians, what “hybrid-use” design really means, and how to navigate the long, expensive road from prototype to regulatory approval.

They cover:

• The tradeoffs between reuse and remanufacturing in hospitals
• Designing inflators that maintain safety and simplicity
• The “Tesla lesson” for medtech
• Why getting from prototype to MDR approval is a 3-year journey before sales even begin

If you’re an engineer or medtech innovator thinking about sustainability, this episode is for you.

Connect with Pablo:
LinkedIn: https://www.linkedin.com/in/pablo-yaniz-gonzalez

Connect with us:
If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, 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]

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.

Dr. Axel Boese has spent years studying how hospitals can innovate sustainably — and one of his biggest insights challenges the status quo of “single-use.”

In most hospitals, medical tools are used once and then thrown away. For something like a cheap plastic syringe, that makes sense. But with a €600 stapler or a €1,300 catheter, the practice becomes both unsustainable and financially wasteful. 

That’s where hybrid-use comes in. Instead of discarding the entire device, hospitals can reuse the critical components while protecting them with inexpensive, disposable covers that maintain sterility. The result: less waste, lower cost, and a smarter path to sustainability.

In this episode, Dr. Boese joins Lucas to explore what’s driving hospitals toward single-use, how adopting hybrid-use could cut waste from high-value medical devices by up to 75%, and how the next generation of medtech professionals can balance patient safety, performance, and environmental impact.

Connect with Axel:

LinkedIn: linkedin.com/in/axel-boese-a7b43a188?originalSubdomain=de

Axel’s company, MEDICS GmbH: https://medics-md.de/

Connect with us:

If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, 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

📺Watch these episodes on YouTube: https://www.youtube.com/@GradicalGmbH

🌍 Learn more about Gradical: https://gradical.ch/

📩 Work with Lucas and the team: [email protected]

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.