Hello everyone and welcome to this guest interview. Today I present to you Lucas R. Pianegonda who is Managing Director and Lead Plastic Expert at Gradical GmbH, which supports you in the medical sector with plastics evaluation, material compliance or material testing.
In this guest interview, we have the chance to learn about medical grade plastics and their selection, what their mantra “Form a better world – with plastics” means, and how one can incorporate sustainability in the medical device environment.
Enjoy the interview!
Tell us about yourself, your current role, and your company Gradical GmbH.
I’m a medical grade plastic expert and I help medical technology companies to choose the right plastic for their applications. This regarding their technical, regulatory and sustainability requirements. I studied material science at ETH Zürich and then went to industry. Initially I worked at a plastic manufacturing company EMS Chemie where I was responsible for material testing and material data models. I then went on to work for a company that produces two component mixing and storage solutions – medmix. There I was responsible for plastic material selection, material compliance and sustainable materials. Armed with this experience I founded Gradical in 2022. Gradical is a consultancy for all things medical plastics and I am simultaneously lead plastic expert and managing director.
A main mantra of yours is to “Form a better world – with plastics” - How do you achieve this and what are your main service and solution offerings?
The goal of medical technology companies is to improve the lives of people. But medical technology companies are facing huge challenges. The regulatory landscape, new sustainability requirements and skilled labor shortage to name a few. Plastics currently have a bad reputation which is undeserved in my opinion. I think plastic are contributing in bringing said medical solutions to market. Medical technology companies are in need of plastic know-how in order to get their product to market and our services enable this. We offer services and trainings regarding plastic evaluation, material compliance and material testing. Our two standard trainings “Sustainable plastics in medical technology” and “regulatory aspects of plastic selection” are very popular. This shows that people are interested in these topics and want to learn more.
How do you define the term “Medical Grade Plastic” and what are the most used Medical Grade Plastics in which applications?
“Medical Grade Plastics” is no protected expression. So a lot of plastics manufacturers call their materials “medical grade” as soon as they have tested some aspects of biocompatibility and there is an application in the medical field. However in 2017 the VDI has put together a guideline on what a medical grade plastic is. The main aspects of the definition are change management, regulatory support and supply security. I think it meets the requirements of medical technology companies and therefore this is the definition I always use.
As for main plastics and their applications: The most used plastics in medical technology, as in all applications, are commodities such as PP, PE and PVC. PE is used for packaging, caps and closures. PP is used for syringes and other disposables. PVC is used for tubing, blood bags, blisters or also for hospital flooring. Engineering plastics and high performance plastics are used where the commodities do not meet the requirements. Examples include clamps from PA6, Lenses from PMMA, surgical devices made from PPSU or implants made from PEEK. The class of thermoplastic elastomers also should not be underestimated too. They are used in applications where softness and elasticity is needed which includes tubing, handles and sealings.
Industries are gradually switching to more sustainable material offering for their products. How is this trend affecting the material selection in the medical device industry in terms of using sustainable plastics alternatives such as recycled, bio-based or biodegradable plastics?
This is one of our expertise. Medical device companies start to look into sustainability more and more. They are still hesitant to using sustainable materials due to the major hurdles to bringing a device to market. If they bring something to market it needs to be a success and therefore they don’t want to make the wrong decision. There are however pioneers that are already using biobased plastics or even recycling plastics in their medical device. Biodegradable plastics seldomly bring advantages over biobased conventional plastics, therefore I think they will stay in niche applications. Recycling plastic have the issue of needing much more quality control and risk management measures, a topic that is already unclear for conventional plastics, this leads to the conservative approach of not using recycled plastics in medical device. I often hear that recycled plastics cannot be used due to “regulatory requirements” this is simply not true. A medical device company has to show that the recycled plastic yields to a safe and effective medical device. Most companies do not know how to show this, not that it is an easy task, and therefore decide against using recycled plastics. The most promising approach to sustainable plastics in the medical field however is the so called, mass balance approach, were the same plastics can be used as drop in solutions for existing grades. This with a vastly improved footprint. Since we believe in this approach we started offering project support and coaching for companies willing to obtain mass balance certifications such as ISCC+.
How do you see “Design for Recycling” in the field of Medical Grade Plastics? In addition, are there already some circular economy examples where medical grade plastics find a second life?
Medical applications cause a significant portion of the plastic waste. I’ve seen studies that estimate it at 3-5 % of the total plastic waste. Another study showed that 80% of plastic waste in hospitals is neither contaminated nor infectious and therefore could be recycled. I think recycling of medical waste has a future. This also means that medical technology companies should think about how to design medical devices, pharmaceutical packaging and in-vitro diagnostics such that they can be recycled. As for examples, Novo Nordisk has launched a take back program for their self-injection pens which they then recycle. Currently there are still down cycling the materials into chairs, but it would not surprise me if it will be possible in the future to manufacture new pens from the recycled material. We have to be cautious tough, plastics are not infinitely recyclable. At some points properties degrade and we need to complement this with other solutions such as biobased or chemically recycled virgin-like plastics.
Where can the readers find out more about you and your offers for the medical device industry?
I mean the best source would definitely be to contact my for a quick exchange. I love meeting new people and whoever is interested in our services, I’m very happy to present them to you. The other obvious source is our website: www.gradical.ch which has gotten an upgrade recently. For the more auditive predisposed: we do also have a podcast Gradical Podcast - Der Podcast zu Kunststoffen in der Medizintechnik | Podcast on Spotify where I interview experts on different topics related to plastics in medical device. The reader might be interested in hearing your interview about high performance plastics.
That was the guest interview with Lucas R. Pianegonda from Gradical – many thanks Lucas for our exchange on topics such as Medical Grade Plastics and their selection, and your motivation to “Form a better world – with plastics” .
Thanks for reading!
Greetings and #findoutaboutplastics
Herwig Juster
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