Mahaut de Villepin-Lambert: I think challenge number one, obviously – compliance is, I think, one of the main challenges because switching to biodiversity-friendly alternatives may require an entire revalidation or delaying the market entry and obviously sometimes increasing the cost. Typically using biodegradable packaging material in a sterile device may require an entire new approval cycle to the FDA or the regulatory bodies like the FDA. And this is time and money that the pharma and medtech company is losing.
A second aspect regarding compliance is that obviously today biodiversity is an indirect priority for regulatory bodies at the moment. The priority number one and will always be quality and safety for the patient when it comes to drug approval.
Another aspect is the globalized and the complex supply chain. Today, in the life science and healthcare industry, they source biological materials, raw ingredients and minerals from very diverse regions. Often, the supply chain is quite fragmented and difficult to handle. And we've seen it during the COVID crisis: being able to manufacture the vaccine for the worldwide population was a challenge because of the supply chain disruption.
And therefore, tracing the impacts on ecosystems, deforestation, over-harvesting of medicinal plants is a challenge because there's no clear diversity monitoring standards today in the industry.
And the third challenge is the tension between the innovation speed and the ecological awareness. The pharma and medtech industry are really under intense pressure to innovate quickly especially during global health crises like the COVID-19 again, I'm mentioning this example several times, but it's been a real eye-opener for many of us.
And environmental safeguards like really sustainable sourcing or habitat assessments can be seen as slowing down the progress despite really the long-term benefits that the industry would take.
So, our solutions helped them to track, typically, in the space of medtech – when you need to submit a new market approval for device, you need to provide one element which is called the device master record that inside you need to detail precisely the requirements, the guidelines that are communicated by the regulatory bodies, what are the different requirements that your medical device is supposed to meet, what are the different tests that you have performed.
We help medtech companies structure the requirements in a proper way based on the regulations so that they perform the right tests, they take the right engineering and design decisions, they are able to track and save the different simulation results, and we help them to facilitate the submission to the FDA. So, this is typically an example of how our virtual twin technology and 3DEXPERIENCE platform help medical device companies to be compliant.
Narrator: Thank you, Mahaut, for joining us and shedding light on the intersection of healthcare innovation and biodiversity. Your insights are a powerful reminder that progress and preservation can go hand in hand. The virtual twin emerges not just as a solution but as a strategy that supports circular R&D, reduces reliance on raw materials, and helps navigate complex regulations.
Thank you for tuning in. We hope you found today's episode valuable. Curious how life sciences and healthcare companies are achieving bio-circular success? Download our ebook to unlock actionable strategies powered by the virtual twin.
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