Perspectives from the Healthcare Ecosystem.

The article “Shaping Europe’s Health AI Pathway with TEF-Health” explores how clinical testing, regulatory awareness, and realistic development environments can prepare technological innovations for successful use in healthcare.

As a practical example, the article highlights the collaboration between Symphera and CEED | Charité.

What the example demonstrates:

• The innovation journey does not begin directly with product validation, but with an analysis of clinical workflows
• Operational constraints and the needs of healthcare professionals are considered from an early stage
• Workshops, expert consultations, interviews, and data-driven analyses help validate key assumptions
• Clinical expertise and regulatory awareness create a stronger evidence base for further development

The collaboration focused on how Symphera’s automated instrument-switching technology could be meaningfully integrated into the realities of the operating room.

The article emphasizes that successful AI and robotics innovation requires more than technical performance. Understanding the clinical context, existing workflows, and the conditions for future implementation is equally important.

This approach also informs the partners’ continued collaboration. Together with Symphera and the German Aerospace Center (DLR), CEED is now contributing to a BMFTR-funded project on multifunctional end effectors for robotic surgery.

CEED provides the clinical perspective and application context, Symphera contributes its digital instrument platform, and DLR brings its robotics and engineering expertise.

➡ Read the full article “Shaping Europe’s Health AI Pathway with TEF-Health”

Representing CEED, Kristin Spandau attended HLTH Europe and returned with a wide range of insights from the international healthtech and innovation ecosystem.

The event provided valuable opportunities for personal conversations, new connections, and exchange with established partners. It once again demonstrated that healthcare innovation emerges where different perspectives come together and new collaborations are built.

Key topics at HLTH Europe included:

• The transformation of healthcare systems
• Prevention and future-ready healthcare delivery
• International collaboration in healthcare
• Connecting clinical practice, industry, and innovation
• Translating new MedTech solutions into real healthcare environments

The discussions highlighted that innovation is not driven by technology development alone. To create meaningful value for healthcare delivery, new solutions must reflect clinical workflows, involve relevant stakeholders, and be translated into real-world settings from an early stage.

The key takeaway: International exchange creates the foundation for new perspectives, sustainable partnerships, and healthcare innovations aligned with the actual needs of clinical practice.

At bio:cap in Berlin, CEED engaged with start-ups, companies, and representatives from research and healthcare innovation.

The event provided space for in-depth conversations, new connections, and insights into emerging ideas across the life sciences and healthtech ecosystem.

Key topics included:

• New approaches and business models in healthcare
• Exchange between start-ups, research, and established organizations
• The conditions required for successful innovation
• The importance of structures, resources, and collaboration
• New perspectives on advancing healthcare solutions

A central insight from the panel “Translating Excellence into Impact” was that talent and strong ideas alone are not enough. People, organizational structures, and resources are essential to translate innovation into practice.

The key takeaway: Healthcare innovation does not emerge in isolation. It requires exchange, strong networks, and the right conditions to turn ideas into sustainable solutions.

At the International Public Summit of our partner TEF Health, held under the theme “Transforming Healthcare with Trusted AI, Robotics and Data”, CEED’s Head of Operations, Denny Chakkalakal, presented how healthcare innovations can be successfully translated into clinical reality.

The presentation focused on three critical gaps that frequently determine whether innovations achieve sustainable adoption in healthcare:

• Gap 1: Problem ↔ Solution
  Have we validated the clinical need?
• Gap 2: Validation ↔ Implementation
  Can the innovation become part of routine care?
• Gap 3: Data ↔ Governance
  Can evidence be generated responsibly?

Drawing on practical examples from projects with partners such as Symphera and Philips, the session highlighted the importance of clinical requirements, workflow integration, governance structures and real-world evidence long before market launch.

The central message of the presentation:

“Trusted AI requires trusted implementation.”

➡ Find Denny’s full presentation here.

Germany Trade & Invest (GTAI) featured CEED and Charité in a recent contribution on Germany’s digital health and MedTech ecosystem.

The feature explores what makes Germany an attractive environment for healthcare innovation, from established MedTech clusters to leading university hospitals.

It highlights how CEED helps bring together clinical expertise, data, research and industry to support the successful translation of innovation into healthcare practice.

Professor Thomas Picht explains how regulatory can be seen as a chance in this process rather than an insurmountable obstacle.

Particular attention is given to Charité’s innovation ecosystem and the Berlin Simulation and Training Center (BeST), which provides realistic testing and development environments for MedTech innovations.

➡ Read the full Germany Trade & Invest feature here.

At Taiwan Night & International Matchmaking during MEDICA 2025, CEED connected with innovators and companies from Taiwan and Europe.

Together with Kalms Consulting, Denny Chakkalakal, Head of Operations at CEED, shared insights into the key requirements for successfully introducing HealthTech and MedTech solutions to the European healthcare market.

The discussion focused on:

• Clinical validation based on real healthcare needs
• Meaningful involvement of users and healthcare professionals
• Reliable data and regulatory requirements
• Understanding clinical workflows and operational conditions
• Partnerships that connect technological development with clinical practice

Taiwan combines strong engineering expertise, rapid innovation cycles, and considerable momentum in smart healthcare. The exchange highlighted that many companies are actively exploring how their technologies can be implemented effectively within European healthcare systems.

The key takeaway: International networking is not optional. It is essential for understanding cultural, regulatory, and clinical realities and for translating innovations successfully into new markets and healthcare environments.

Thank you to Medtex Medsolution Ltd, the Ministry of Economic Affairs, the Metal Industries Research & Development Centre, and the Industrial Technology Research Institute for the invitation and organization.

At the Shenzhen Futian – Berlin Economic and Trade Cooperation Forum, CEED engaged with representatives from business, innovation, and healthcare from Germany and China.

Thanks to the introduction by Johannes Vietzthum, CEED had the opportunity to present its work and connect with stakeholders from Shenzhen as well as German organizations with strong ties to China or an interest in establishing new collaborations in the region.

The discussions focused on:

• Opportunities for collaboration with Charité and CEED
• Insights into Germany’s clinical innovation landscape
• The joint development of MedTech solutions based on real clinical requirements
• Building long-term connections across different healthcare systems

The conversations highlighted a strong interest in gaining a deeper understanding of clinical practice in Germany and developing innovations in closer alignment with healthcare needs.

The key takeaway: International exchange creates new perspectives and opportunities for collaboration, particularly when openness, professional curiosity, and diverse experiences come together.

The first anniversary of sphin-X e. V. brought together more than 120 representatives from industry, hospitals, academia, and politics in Berlin.

The event focused on how reliable structures can ensure that data spaces move beyond theoretical concepts and become practically usable for healthcare delivery, research, and development.

Key topics included:

• Collaboration between industry, policymakers, and clinical institutions
• Data interoperability and FAIR principles
• Digital sovereignty in healthcare
• Precision, data quality, and governance
• The practical implementation of a shared health data space

A particular highlight was the demonstrator, which illustrated how a shared data space can function in practice and which organizational and technical requirements are essential for its successful implementation.

The key takeaway: Progress emerges when different perspectives come together and exchange takes place openly across institutional boundaries.

This collaborative approach is also central to CEED: Sustainable healthcare innovation develops when clinical practice, industry, and research work together on shared solutions.

Frontiers Health 2025 once again brought together leaders from healthtech, life sciences, healthcare, research and investment to discuss current developments and future directions in healthcare innovation.

As part of the masterclass “How Hospitals can Develop Service Business Models for Healthtech”, hosted by Research2Guidance, Denny Chakkalakal, Head of Operations at CEED, joined a panel of experts to discuss the evolving role of hospitals as innovation partners for healthtech companies.

The session explored how hospitals can leverage their clinical, regulatory and scientific expertise to support innovation and develop sustainable service models in collaboration with industry partners.

Representing CEED | Charité, Denny shared insights into how clinical reality, research and innovation can be connected to develop solutions that address real healthcare needs and support successful implementation in practice.

The discussion highlighted that hospitals are not only users of new technologies but can also play an active role throughout the innovation journey, from early development and validation to implementation and adoption.

➡ Learn more about Frontiers Health: https://frontiers.health

How can true collaboration between clinical practice, research and MedTech succeed?

In this podcast series, CEED experts join the team from Rocketing Healthcare to talk about challenges, opportunities and key levers for innovative product development – straight from the clinical environment of Charité.

Two episodes of the special series are already online – offering valuable insights into how CEED works at the interface of healthcare and innovation, and how startups can benefit from structured access to clinical expertise.

🎧 Episode 1: How the Charité Spin-off CEED Supports Healthcare Startups
With Prof. Dr. Thomas Picht and Denny Chakkalakal

The story behind CEED’s founding, common startup pitfalls – and how CEED acts as a bridge between the clinical world and the HealthTech scene.

🎧 Episode 2: Tapping into Clinical Knowledge – How CEED Enables Innovation
With Prof. Dr. Thomas Picht and Denny Chakkalakal

Insights into CEED’s formats – including expert panels, usability testing and workflow analysis, flexible contracting with Charité, and why real participation means more than a buzzword.

🎧 Episode 3: Medical Device or Not? Regulatory Clarity for HealthTech Startups
With Claudia Tessenow and Prof. Dr. Thomas Picht

When is a product considered a medical device – and what does that mean for approval, claims, and the business model?
Insights into MDR, intended purpose, common mistakes, AI & the AI Act – and how CEED supports startups as a “speedboat” through the proccess

🎧 Episode 4: How Clinical Studies Drive Market Success for MedTech Products
With Dr. Matthias Fehlinger and Prof. Dr. Thomas Picht

The episode explores types of studies, strategic planning, and common pitfalls for startups.
Find out why early consultation is crucial – and how access to Charité creates a real competitive edge.

🎧 Episode 5: Why Good Usability Makes MedTech Products Successful
With Laura Schönijahn and Prof. Dr. Thomas Picht

The episode explores why usability and UX are key for market success, patient safety, and regulatory approval.
Find out how early user feedback drives product quality — and why UX is much more than a “nice to have.”

Listen on Podigee! 

Listen on Spotify! 

Hosts: 

Matthias Schwarz

Peter Lutsch

Rocketing Healthcare

How can hospitals turn clinical expertise into real innovation and value?

In the Health Leaders interview series by Berlin-based Digital Health analysts Research2Guidance (R2G), Denny Chakkalakal, Head of Operations at CEED, shares insights into CEED’s role as the Charité’s internal consulting unit for MedTech and digital innovation.

Key topics:

• Structured access to clinical expertise for startups and MedTech companies
• Support throughout the entire innovation process – from idea to market entry
• Close collaboration with clinical departments at Charité
• CEED formats like usability tests, expert panels, and workflow analyses

➡ Read the full interview

About Research2Guidance

Research2Guidance (R2G) is a global strategy and market research company specialized in digital health. With their platform R2GConnect, they match startups, corporates and healthcare organizations worldwide to foster innovation partnerships.

CEED is proud to be part of this international network and to offer tailored services for global partners.

➡ Explore R2Gconnect Deals

AI-Powered Software in Medical Technology: Navigating Complex Regulatory Challenges
AI-driven software in medical technology raises complex regulatory questions: When is it classified as a medical device under the MDR? When does it also fall under the AI Act as a high-risk AI system?

Claudia Tessenow (CEED) and Christian Teichter (Schürmann Rosenthal Dreyer Attorneys) analyze the key criteria for qualification and classification, providing manufacturers with practical guidance.

This article explores the role of intended purpose, how risk classification is determined under the MDR, and when an AI system is considered high-risk under the AI Act. Featuring clear examples and concrete guidelines.

➡ Read the full article here!

This webinar is designed to help startups gain a clear understanding of the MDR’s foundational requirements and how to apply them effectively. In addition, a MedTech company from our capital region will share their hands-on experience on their recent MDR certification journey.

Time:

Tuesday, 25th of February, 1-2pm

Registration:

Click here to register

Agenda:

Part 1: MDR Overview Presentation by Claudia Tessenow, Senior Consultant Regulatory & Clinical Affairs, CEED @ Charité Healthcare Services GmbH

Definition and Classification of Medical Devices:What qualifies as a medical device?
How is the product class determined, and what are the implications for the certification process?
Quality Management System (QMS):Why a QMS is essential and how to establish one effectively.

Part 2: Company view: Experience of recent MDR certification journey by Dr. Juliane Dinter, Quality and Regulatory Affairs Manager at Magnosco GmbH

The MDR certification journey: challenges and solutions. Building a functional Quality Management System (QMS).
Practical tips to avoid pitfalls and save time.

Part 3: Q&A

Please note:
Participation in this online event is free of charge. Please register under the above link. You will receive a dial-in link one day prior to the event.

In case of any questions please contact Flavia Kruse under Flavia.Kruse@berlin-partner.de.

Target group: Medical device startups

Source: Cluster HealthCapital

CEED introduces itself and demonstrates how to efficiently integrate clinical expertise, usability testing, and the incorporation of clinical data into medical technology development.

A special highlight is the tour through the newly opened Berlin Simulation and Training Center (BeST).

Time & Location: 

On Februry 26, from 2:00 PM to 4:30 PM, we invite you, together with SPECTARIS, to an exclusive meet-and-greet at the Rahel Hirsch Center in Berlin.

Registration:

Please fill out the contact form below. We will get back to you promptly with a confirmation.

Agenda:

Introduction (45min)

• CEED Opens Doors 
  ➡ Insight into the CEED platform and its services for medical technology companies.
• Regulation 3.0 – “What Does the AI Act & Data Act Mean for MedTech Manufacturers”
  ➡ Legal experts from Schürmann Rosenthal Dreyer Attorneys explain.

Exclusive Tour of the Berlin Simulation and Training Center (BeST) (45min)

• Experience Real-World Testing Up Close
  ➡ Discover the Berlin Simulation and Training Center (BeST) with state-of-the-art test environments for medical devices.

Meet the Experts (1h)

• Networking with CEED & Industry Leaders
  ➡ Exchange over drinks with experts from research, regulatory, and usability fields.
• Guest Contribution on Interoperability: “AI, Digital Health & Interoperability”
  ➡ Dr. med. Carina Vorisek provides practical insights into the challenges and solutions of modern medical technology.

Targetgroup:

The event is aimed at professionals and executives from the medical technology industry, especially decision-makers in the areas of:

Research & Development
Product Management
Regulatory & Clinical Affairs
Usability
Management

When Does Software Become a Medical Device – and When a High-Risk AI System?

Claudia Tessenow (CEED) and Christian Teichter (Schürmann Rosenthal Dreyer Attorneys) provide a concise overview of the regulatory requirements.

Regulatory Affairs Expert Talks 2025

Date & Location: April 1–2, 2025 | Würzburg

The Regulatory Affairs Expert Talks is a leading conference on regulatory topics in medical technology. Gain practical insights and valuable recommendations on the qualification and classification of AI medical devices.

Learn more & register now! 

Regulating AI-powered medical devices is becoming increasingly complex. In addition to the MDR, the EU AI Act introduces new regulatory requirements. But when is AI software considered a medical device – and when is it classified as a high-risk AI system? And what does this mean in practice for manufacturers?

Get clear answers from:

Claudia Tessenow (Regulatory & Clinical Affairs, CEED @ Charité)
Christian Teichter (IT Law Expert, Schürmann Rosenthal Dreyer)

Date: May 14, 2025 | Time: 11:00 AM –12:30 PM
Location: Online – Link will be sent upon registration

Expect hands-on examples, practical guidance, and clear classifications – especially relevant for startups.

Click here to register!