# **🚨 Honest Talk about PFAS in the Medical Devices Industry – How Is the Industry Responding?**

First, the good news: you can find bellow our summary for free – because collective expertise should be shared, not siloed. Especially here in Switzerland, collaboration drives progress.

✅ Last week, we hosted the first-ever “Honest Talk” event co-hosted by Swiss Medtech, gathering experts across the industry to tackle one of our most pressing topics: PFAS regulations.

We asked: 
🔍 What urgent steps must the MEDTECH industry take?
 ⚖️ How can we stay compliant and pragmatic?
 ❓ What’s still unclear – and when will we know more?

With new regulations from ECHA and EPA, the pressure is real. But the mindset was clear: solutions over fear. 💡

📝 Based on the discussion, Innofuse created a free one-pager with actionable insights. Want a copy? Drop us a message on info@innofuse.swiss, and we’ll send it your way.

📢 Bonus: A new Community of Practice (CoP) is launching on the Innofuse platform – open to all – for ongoing exchange, events, and learning around PFAS and regulatory challenges. Link to the CoP: [Link](https://platform.innofuse.swiss/initiatives/0ee330e7-baaf-4268-859b-211a34f66087)

Let’s keep the momentum going. 

Big thanks to Dr. Werner Schneider & Dr. Philippe Hasgall by Zimmer Biomet, Prof. Dr. Marco Rupprich by Hochschule für Life Sciences FHNW, Bernhard Pultar by POC APP AG, and to all our engaged participants from Camlog, Medartis, Alcon, Metecon Schweiz GmbH, and Swiss Medtech.

#PFAS #Medtech #HonestTalk #MedicalDevices #Innofuse #SwissMEDTECH #CommunityOfPractice #Regulations


# **Summary: Honest Talk by Innofuse - CMR-PFAS - 24th April 2025**

**1.	CMR and PFAS in the Medical Device Industry – Key Takeaways**

Lecture by Werner Schneider, Zimmer Biomet
**Use of PFAS**

•	PFAS are utilized due to their unique properties: chemical resistance, biocompatibility, inertness, flame resistance, and low specific weight.

•	PFAS are ubiquitous. Any substance containing fluorine should be verified against regulatory lists (e.g., CAS, POP).

**Health and Environmental Concerns**

•	Although PFAS are not inherently dangerous, their long-term accumulation is persistent, bio accumulative, toxic, and mobile.

•	Experiments with zebrafish (Zebrafish experiments) have shown PFAS can have endocrine-disrupting effects.

**Handling PFAS**

•	Upon identification of PFAS, objectives are to replace them, minimize usage (with annual reporting for derogated uses), and control emissions.

•	Exception lists exist for substances without viable alternatives.

**Regulatory Compliance and Challenges**

•	The medical device industry faces a complex web of environmental regulations, making compliance extremely difficult and at times seemingly "unmanageable."

•	Relevant regulations include REACH, RoHS, CLP, EU MDR, POP, BPR, PFAS-specific regulations, CA Prop 65, and TSCA (U.S. REACH equivalent).

•	Manufacturers must maintain Material Safety Data Sheets (MSDS).

•	CAS numbers should be centrally stored and monitored to track newly regulated substances.

**Life Cycle Assessment**

•	Effective life cycle management requires controlling the chemical supply chain, from raw materials through design, production, transportation, use, and end-of-life disposal.

•	Relevant standards: ISO 14040 and ISO 14044.

**Insurance and Supply Chain Risks**

•	Insurance companies are increasingly withdrawing coverage from companies handling PFAS, with some U.S. insurers cancelling policies immediately.

•	Major suppliers like 3M plan to phase out all PFAS-containing products by the end of 2025 (3M will completely phase out PFAS), causing supply chain disruptions as key substances become unavailable.

•	These disruptions could impact processes, batch production, and overall material availability.

**2.	Summary of Most Challenging Topics Regarding CMR/PFAS**

**Materials**

•	Identifying which materials, from patient-contact substances to auxiliary materials, contain CMR (Carcinogenic, Mutagenic, or toxic for Reproduction) substances.

**Supplier and Supply Chain Management**

•	Managing suppliers who often lack awareness or understanding of CMR and PFAS substances.

**EO Sterilization and Processes**

•	Understanding the role of CMR substances in Ethylene Oxide (EO) sterilization processes and exploring possible alternatives.
Lack of Knowledge, Expertise, and Support:

•	There is a strong need for accessible expertise and guidance to navigate the complexities surrounding CMR and PFAS management and regulation.

**3.	 Summary of Brainstorming on Supplier and Supply Chain Management**

**Key Concerns**

•	Source Identification: Determining where PFAS enter the supply chain remains a critical issue.

•	Process and Product Analysis: Identifying processes and materials (e.g., detergents) potentially impacted by PFAS restrictions. Analysing whether PFAS are present in final products to assess business risks.

**Strategic Supplier Engagement**

•	Considering collective action through industry associations like Swiss Medtech or MedTech Europe, although current efforts are insufficient.

•	Acknowledging that even large corporations struggle to manage PFAS risks; mid-sized firms can only mitigate risks through detailed analysis of their own products and production processes.

**Industry Support and Regulatory Environment**

•	MedTech Europe has issued a high-level position paper (position paper), but no globally harmonized solutions exist, particularly for non-European suppliers.

•	The MedTech industry proposes a 12-year phase-out period; however, some suppliers may exit the market much sooner, increasing risk.

**Needed Actions**

•	Develop clear guidance on conducting thorough supply chain and production process analyses, including best practice examples.

•	Establish a comprehensive strategy to manage PFAS risks, covering product and production chain analysis, risk mitigation, and regulatory tracking.

	


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PFAS in MEDTECH Industry

First Honest Talk

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# Honest Talk by Innofuse: CMR-PFAS

* **Date:** 24th April 2025 | Time: 15:30 - 17:00
* **Location:** Innofuse, @Orbiz Basel, Aeschengraben 9, 4051 Basel
* **Objective:** Join us for an insightful and collaborative session where we address the current MedTech challenges and brainstorm effective solutions as a team. This interactive event is designed to foster open dialogue and problem-solving, bringing industry professionals together to tackle real-world challenges.
#### Event Highlights
* Dive into the CMR Topic: Gain valuable insights into the latest trends and challenges in CMR  Substances (carcinogenic, mutagenic, or toxic to reproduction) within the MedTech industry.
* Learn about PFAS and its Impact: Understand the risks and regulatory implications of PFAS (Per- and Polyfluoroalkyl Substances) and how it affects the MedTech business.
* Collaboration: Participate in a team-based brainstorming session with other MedTech professionals to identify practical solutions to mitigate CMR issues.
* Follow-Up: Regular check-ins during future Honest Talks to track progress and resolve any new challenges that arise.
#### Speakers
* Dr. Werner Schneider – Zimmer Biomet
* Dr. Phillipe Hasgall – Zimmer Biomet
* Bernhard Pultar – POC APP
#### Why Attend?
This is your chance to collaborate with peers, share insights, and find actionable solutions to common challenges in the MedTech industry. Don’t miss out on the opportunity to connect, learn, and drive meaningful change!

**The event is free of charge!**

**Featured by the Swiss Medtech Association.**


Fill out this form to join our event

# Honest Talk by Innofuse: CMR-PFAS

* **Date:** 24th April 2025 | Time: 15:30 - 17:00
* **Location:** Innofuse, @Orbiz Basel, Aeschengraben 9, 4051 Basel
* **Objective:** Join us for an insightful and collaborative session where we address the current MedTech challenges and brainstorm effective solutions as a team. This interactive event is designed to foster open dialogue and problem-solving, bringing industry professionals together to tackle real-world challenges.
#### Event Highlights
* Dive into the CMR Topic: Gain valuable insights into the latest trends and challenges in CMR  Substances (carcinogenic, mutagenic, or toxic to reproduction) within the MedTech industry.
* Learn about PFAS and its Impact: Understand the risks and regulatory implications of PFAS (Per- and Polyfluoroalkyl Substances) and how it affects the MedTech business.
* Collaboration: Participate in a team-based brainstorming session with other MedTech professionals to identify practical solutions to mitigate CMR issues.
* Follow-Up: Regular check-ins during future Honest Talks to track progress and resolve any new challenges that arise.
#### Speakers
* Dr. Werner Schneider – Zimmer Biomet
* Dr. Phillipe Hasgall – Zimmer Biomet
* Prof. Dr. Marco Rupprich – FHNW
* Bernhard Pultar – POC APP
#### Why Attend?
This is your chance to collaborate with peers, share insights, and find actionable solutions to common challenges in the MedTech industry. Don’t miss out on the opportunity to connect, learn, and drive meaningful change!

**The event is free of charge!**

**Featured by the Swiss Medtech Association.**

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Join us for an insightful and collaborative session

Honest Talk by Innofuse & Swiss MEDTECH: CMR-PFAS

**The Future of Work – AI-Driven Collaboration & Recruitment**
February 2025 | Innofuse

Following our recent presentation at the Innovation Booster Artificial Intelligence, we’re excited to share key takeaways on how AI is transforming collaboration and recruitment.

With 85% of companies facing skills gaps (McKinsey, 2025), the challenge lies in balancing efficiency and personalization while ensuring ethical AI use. Experts from Rockstar Recruiting and Innofuse showcased innovative tools tackling this issue:

Rockstar Recruiting’s AI-driven VC screening tool streamlines candidate selection, making hiring faster, fairer, and more cost-effective.
Innofuse’s skill-based matchmaking platform connects project stakeholders across organizations, fostering seamless collaboration and knowledge exchange.

Read the full article here: [Link](https://ai-booster.ch/the-future-of-work-how-ai-enables-new-collaboration-and-recruitment-strategies/)

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Innofuse @ AI Innovation Booster by Innosuisse

## **Join Us for Our Open Door Day & Inauguration Party!** 
**[Registration mandatory](https://forms.office.com/Pages/ResponsePage.aspx?id=DQSIkWdsW0yxEjajBLZtrQAAAAAAAAAAAANAAXon2LBUOEZFQVlWWUlRVEoyWTMwNjUwRDRZNDVRRS4u&lang=en)**

**Date:** 07.11.2024

**Location:** Aeschengraben 9, 4051 Basel

**Time:** Doors open at 17:00


We’re thrilled to invite you to our Open Door Day and Inauguration Party in Basel! This special event is a chance to get an insider’s view of what we do, meet like-minded individuals, and celebrate our journey together. Here’s a sneak peek at the agenda:

# **Agenda**

**17:00** – Door Opening & Start of Innofuse Walk Through

Step inside and explore our workspaces with the Innofuse Walk Through, where you’ll experience the heart of our projects and meet our team.

**17:30** – Networking Apéro

Connect with industry professionals and other visitors over light refreshments.

**18:30** – Ticket Raffle

Participate in our raffle for a chance to win exclusive prizes!

**19:00** – Inauguration Party

Celebrate the official inauguration with us as the evening transitions into a lively party atmosphere!

Throughout the event, you can look forward to partner exhibitions and interactive contests for visitors. Keep your curiosity alive as there will be surprises around every corner.

We’re looking forward to welcoming you to an unforgettable evening in Basel! **[Registration mandatory](https://forms.office.com/Pages/ResponsePage.aspx?id=DQSIkWdsW0yxEjajBLZtrQAAAAAAAAAAAANAAXon2LBUOEZFQVlWWUlRVEoyWTMwNjUwRDRZNDVRRS4u&lang=en)**

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let's get the Innofuse party started!

07.11.2024 Open Door Day & Inauguration Party

# What’s Happening at Innofuse
After a year of dedicated development, Innofuse officially launched its web-platform on September 6th. In collaboration with 25 key opinion leaders from academia and industrial R&D, we have made our vision a reality. While onboarding is in full swing, our team continues to work on enhancing the platform every day.
New members are joining us daily, and we are gradually onboarding key institutes, companies, and associations. The first collaborators are already visible on our website, with more to be showcased soon. Stay tuned as our network grows!
Our first version includes the “My Innofuse” Cockpit, the “Initiatives Hub”, the “Networking Hub”, and the “Innofuse Reactor”, our initial search and matchmaking engine. Our roadmap is packed with exciting new features - stay tuned!

We will soon organize a live training session titled 'How to Innofuse.' If you would like to register for this training, simply join the Initiative on the Innofuse platform. Instructions on how to find it are provided at the bottom of this article.

# What’s in It for You
To support our early adopters, we’ve extended the early bird offer throughout the onboarding phase. Membership prices will increase gradually as we grow, so the sooner you join, the more you’ll save.
Additionally, we are partnering with third parties to offer our members access to a wide range of valuable services at favorable rates. These services span across moderation, innovation consulting, individual development and mental health support, including burnout prevention - ensuring that our members have the tools they need to thrive in all aspects of their professional journey.
We’re delighted to welcome members from a wide range of industries and sectors, all interested in becoming part of this collaborative innovation ecosystem.

**Get your memebership** [HERE](https://www.innofuse.swiss/products)

# Upcoming Events
Our first event will be the Inauguration Party at our physical space in Basel City, one tram stops from Basel SBB! This will be your opportunity to:
Learn more about Innofuse, explore our first co-creation space, meet the founding team in person We’re also inviting the 25 expert key opinion leaders who helped shape Innofuse, alongside all current and potential members.
The event will feature a special format, and yes, there will be prizes to win - rumor has it that a few memberships will be up for grabs! The event is free to attend, but registration is required. Spread the word to anyone interested in joining the Innofuse ecosystem!
Location: ORBIZ Basel, Aeschengraben 9, 4051 Basel
Date, Time: 07.11.2024, start 17:00
Duration: open end

**Register for this event:** [HERE](https://forms.office.com/Pages/ResponsePage.aspx?id=DQSIkWdsW0yxEjajBLZtrQAAAAAAAAAAAANAAXon2LBUOEZFQVlWWUlRVEoyWTMwNjUwRDRZNDVRRS4u&lang=en)
# 
# Behind the Scenes at Innofuse
The Innofuse founder team created this section to share insides from navigating startup challenges - perfect for startups or anyone dreaming of entrepreneurship!

This edition shares insides in re-thinking company structure and corporate legal entity.
The Innofuse Founder Team, consisting of 6 founders, including 3 medical technology experts with decades of experience in research and product development, 2 senior software developers/architects, and 1 finance expert. The creation of Innofuse stems from a shared challenge: the lack of visibility and connectivity to expertise and technology in our field and across other disciplines.

### The Starting Point
Well, the idea is there. The solution has been thought through over the years, and the personas have been identified. The different "whys" for each persona type have been recognized, as well as the win-win connection in valuable interactions with a real and practical purpose - check. Realizing what an ecosystem of several thousand experts in the field of high-tech R&D could achieve if they join forces is mind-blowing. Not only does the field of action span from private to corporate and public sectors, but it also reveals surprising collaboration setups.

The scope of action within such an ecosystem ranges from collaboration to maximize innovation and value for the benefit of our members, to the ethical responsibility of letting knowledge flow between experts, students, and academia, and vice versa. It even extends to humanitarian project support, providing free access to knowledge and expertise that directly impacts people’s quality of life, such as for surgeons and clinicians, as well as involving expertise that would otherwise be lost, for example, from retired experts. The mission was clear: the importance of the solution is bigger than us, and it needs to be set up the right way. We are clearly purpose-driven.

So, what’s next? Founding the organization to give it structure, a budget, and a defined team to work and interact with other entities. But what type of organization is the right one? Talking to people reveals that 10 people will offer 8 different opinions. The purpose is not understood by everyone, which makes us scratch our heads about how to market a solution that serves 14 different sets of "whys," especially since such an ecosystem doesn't yet exist in Switzerland. But more about marketing and how we navigated that bottomless pit in another newsletter 😊.

So, the question remains: which structure? A non-profit organization since we are purpose-driven? Well, in the beginning, it wasn’t clear if we could reach the market without investors. The question of a social enterprise (non-sellable and therefore not investable by professional investors) was taken off the table, though it remains part of our credo. We state "non-profit oriented" because we aim to cover costs and further develop the Innofuse solution, prioritizing this over maximizing profit. However, we needed an organizational structure that could pull the emergency rope and call for investors. The most suitable options were a limited liability company (LLC, GmbH) or a public limited company (PLC, AG).

The decision was made democratically, with the goal of being small and as uncomplicated as possible in the founding process. Even though we had to finance ourselves like a PLC/AG (and that’s another story), we chose to establish an LLC/GmbH. We then set up the core team, the extended team, and the volunteering experts (Key Opinion Leaders) from all 14 persona types as the voice of customers from the very beginning.

### The Factor “Money”
Along the way, it became clear that our limited resources were demanding, and we knew that we would have services that help the ecosystem, individuals, and projects that would not cover their own costs through membership fees. So, we are cross-financing these activities because it is the right thing to do, and it still enriches the entire ecosystem.

### The Investor’s Dilemma
Understanding the investor landscape and the grey areas that come with different types of investors is one thing. Everyone knows how this game is played. However, one thing that wasn’t immediately clear to all of us is that the final endpoint for a company with investors in its initial setup is always the same: sell the company for a higher value than you bought it. It sounds clear and simple - right?

But what do you do with a company that is purpose-driven and has a high-impact concept, which you want to remain in the hands of those who follow its valuable mission? No matter what kind of investor, business angel, or venture capitalist you involve, they all eventually need to sell the company once it reaches a certain value. The only differences are in the timing and the risk profile.

The second eye-opener is that when the investor decides to sell the company, you might not be able to afford to buy it back - there’s almost no chance. The probability of having the funds to do so is so low that only a handful of today’s well-known, large companies have been able to pull it off.

As a result, we have stepped away from having investors as of today!

### Public Interest - Purpose Driven with Economical Impact
Partnering with public institutes and departments might come to mind for some. We did receive one inquiry from someone working for a canton department. We asked this person how much decision-making authority they had and how long it typically takes to make budget-related decisions requiring additional resources. You can imagine the answer - it wouldn’t serve the mission quickly or effectively enough.

Speaking with authorities and well-known, publicly funded, and trusted organizations revealed similar feedback: "Your solution is valid, relevant, and needed. We should invest in and support your organization." So, what’s holding them back? The answer, while surprising, is crystal clear: first, as a publicly funded organization, it is difficult to justify financial support for a for-profit entity. The process of releasing funds and convincing all stakeholders is so exhausting that the reluctance to do so seems endless. However, it's not impossible and is still under discussion…

Even though the necessity of our solution and its positive impact on the Swiss economy - both nationwide and regionally - are clear, many players (associations, foundations, etc.) struggle to help us financially. Attracted by the importance these organizations remain in contact with us and try to help. And it works, at least partially. The problem is that getting even one single Swiss Franc from these pots, feels like undertaking a complicated surgical intervention requiring the help of the entire universe.

So what’s wrong with them? Well, actually, it’s not them - it’s a choice we made early on. Being confronted with questions from these organizational leaders revealed an unseen complication:
"Who can assure us that you won’t sell the company once you reach significant and critical mass?"
"What if we finance you, and you simply shift your business model to maximize profit?"

Side note: pushing forward with an organization like Innofuse without investor support is incredibly difficult, and while it gives you credibility to some extent, it doesn’t erase the fact that you’re still able to sell the company or completely pivot your business strategy.

In the rush to get Innofuse going and to do "good things," we overlooked this perspective.

### How to Secure Additional Support for Innofuse’s Non-Profit Sector
A potential solution lies in splitting the organization into two entities. One part would remain the for-profit LLC/GmbH, while the other would be a non-profit, designed to cover only non-profit-related costs. This setup would allow us to secure funding in a non-sellable container with a clearly defined scope. 

The founder team is currently exploring different organizational structures and the legal aspects of this potential split.

We will keep you updated in the next newsletter, so stay tuned!

Thank you for being part of the Innofuse journey! We are looking forward to continuing building this community with you. Stay tuned for more updates, and we hope to see many of you at our upcoming events!


Warm regards,

**The Innofuse Founder Team**




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