The new Prognos study commissioned by the Federation of German Industries (BDI) presents impressive figures: Innovations in the area of medical devices can save up to 9 billion euros annually in the German healthcare sector — through outpatient care, AI-based diagnostics, robot-assisted systems and intelligent materials such as 3D printing.

That is more than just cost efficiency. It is a signal to health policy: Innovation is not a luxury, but a necessity. The question is not whether we can afford innovations in medical devices — but whether we can afford to block them. The highest savings potential lies in outpatient care, where almost 3 million cases could generate savings of over 6 billion euros.

Where is the challenge?

While the economic potential is clear, the complexity of regulation is growing with strict requirements for transparency, safety, and clinical evidence. High-risk medical devices require robust data quality, documented human monitoring, and continuous performance monitoring.

This is not an obstacle, but the basis for trust.

Manufacturers who see these requirements not as hurdles but as quality features will establish themselves on the market. They will win over patients, doctors and payers because their products are not only innovative, but also evidence-based and trustworthy.

At MEDIACC, we support manufacturers in exactly this: from study planning to generating clinical evidence to conformity assessment in accordance with the Medical Device Regulation (MDR), the In Vitro Diagnostics Regulation (IVDR) and the Artificial Intelligence Regulation (AI Regulation). Because solid regulation and innovation go hand in hand.

The message is clear: The future of healthcare lies in the intelligent combination of regulatory excellence and economic efficiency.

❓ How do you navigate your path to regulatory compliance with innovative medical devices?

#Innovation #Medizinprodukte #Medizinprodukteindustrie #ZukunftderMedizin #KlinischeStudien

COVID-19 is no longer the monster of 2020 — but it's not a harmless cold either. 🦠 The level of danger is now at the level of influenza. Why should we take them both seriously?

Here are the facts:

 🔹 Similar risks: Both viruses affect similar risk groups. COVID-19 is just as dangerous as the flu today.

 🔹 STIKO recommendation: Booster vaccinations for everyone aged 60 and over, previous patients and nursing staff. Why Because vaccination protects against severe cases!

 🔹 Study document: A Danish study involving almost 900,000 people over 65 years of age shows that booster shots work!

 🔹 Current data: Hospitalizations and deaths from COVID-19 and influenza are comparable. (data up to week 35, season 2024/2025)

 🔹 Vaccination quotas: Only 20.9% of people over 60 years of age have been vaccinated against COVID-19 — compared to 38.2% for the flu vaccination. Too little! 😮

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Conclusion: COVID-19 and influenza are both dangerous. Particularly important for risk groups. 💪

 #Gesundheit #Impfen #COVID19 #Influenza #KlinischeWissenschaft

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Agents4Science 2025, hosted virtually by Stanford University, marked a breakthrough in scientific research a few days ago!

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For the first time, artificial intelligence agents were recognized both as lead authors and as peer reviewers in a specialized conference environment. This breakthrough approach explored how AI systems can autonomously generate hypotheses, analyze data, and produce research results that are openly evaluated by a diverse community of researchers and technologists.

At MEDIACC, we believe that such transparent integration of AI is groundbreaking. The requirement for full disclosure of the use of AI enables clear standards and accountability and paves the way for improved scalability, faster document processing, and increased efficiency in data analysis and reporting. This opens doors for accelerated innovation and enables the development and dissemination of new therapies and medical solutions faster than ever before.

However, these opportunities also entail important responsibilities. The rise of AI-powered scientific research requires robust ethical guidelines, transparent attribution, and strict oversight to prevent distortions, misinterpretations, or misuse of sensitive health data. Standards for validation and reproducibility must keep pace with technological progress, and data security remains paramount.

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What is your opinion on AI-generated clinical research? A dream come true or an absolute nightmare?

#KI #MedizinischeInnovation #Ethik #ZukunftDerWissenschaft #Interaktion

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The EU's Joint Clinical Assessment (JCA) is a milestone for medical devices and in vitro diagnostics (IVDs) — a structured, EU-wide process for generating, analyzing and evaluating clinical data that ensures safety, performance, and compliance with regulatory standards.

But what does that mean for manufacturers, healthcare systems, and patients? Let's take a closer look:

🔍 What is a joint clinical evaluation (JCA)?

A systematic, collaborative evaluation of clinical evidence for high-risk medical devices (class IIb/III) and high-risk IVDs (class D). The goal? ✅ Harmonised EU-wide assessments — avoiding duplicate national reviews ✅ Faster market access — Using shared scientific evidence across Member States ✅ Increased patient safety — ensuring consistent, high-quality assessments.

📜 The legal framework: Two important EU regulations

📌 Regulation (EU) 2021/2282 (HTA Regulation, Dec. 2021)

📌 Implementing Regulation (EU) 2025/2086 (Oct. 2025)

🎯 Why is that important?

✔ 💡 Efficiency: One submission, 27 markets — reducing redundant national reviews ✔ ⏳ Speed: Faster availability of innovative medical devices across the EU. ✔ 💰 Cost savings: reduced administrative burden for manufacturers and authorities. ✔ 🌍 Competitiveness: A more attractive EU market for medtech innovations. ✔ 🏥 Impacts on patients: Higher quality and safety in healthcare through standardized assessments.

🔗 The big picture

By avoiding duplication of efforts, the JCA system pursues the following goals: ➡ Accelerating patients' access to cutting-edge medical technologies ➡ Strengthening trust in EU regulatory processes ➡ Reducing fragmentation in the evaluation of healthcare services.

📩 Let's talk about it! Schedule a non-binding appointment to discuss how we can help you optimize your clinical evaluation and market access strategy.

#MedTech #MedicalDevices #HealthcareInnovation #ClinicalEvaluation #JCA

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We are proud to announce that our groundbreaking study is published in the renowned journal Cancer & Metabolism!

This article is the result of many years of efforts to resolve the ongoing debate and gain new insights into the effects of pressure-adjusted static compression (PSC) in patients undergoing chemotherapy — particularly those who develop chemotherapy-related peripheral neuropathy (CIPN).

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What was investigated? We investigated how PSC affects microvascular perfusion (blood flow to the smallest vessels) and aerobic metabolism in cancer patients undergoing chemotherapy. This focus is critical because CIPN is a common, potentially debilitating side effect where nerve damage can impair quality of life and may even force a life-saving interruption in treatment.

Key findings:

The PSC, applied using standardized pressure and palm pads, resulted in significantly increased microvascular perfusion in cancer patients, even those who already had CIPN.

Interestingly, this improved blood flow was accompanied by a reduction in aerobic metabolism in the affected tissues, which indicates a protective change in the tissue environment under compression.

These findings challenge previous hypotheses that compression could reduce local blood flow and thus worsen neuropathy. Instead, PSC appears to support vascular health and tissue oxygenation.

What does this mean for cancer patients?

For patients who suffer from or are at risk of CIPN, PSC represents a promising non-pharmacological approach that protects the nerves and potentially improves everyday functions. The well-tolerated and easy-to-perform intervention supports microcirculation without increasing metabolic stress on already damaged tissue.

Why is that important?

There are currently no generally effective prevention or treatment options for neuropathy caused by chemotherapy. With increasing evidence from clinical trials and this groundbreaking study, pressure-adjusted static compression is becoming a viable, evidence-based strategy to prevent or alleviate nerve damage — and to help cancer patients sustain life-saving therapies longer and with fewer symptoms.

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For oncologists, rehabilitation specialists, and patient advocates: Integrate PSC into supportive treatment pathways early on and monitor ongoing research, as these findings could soon lead to changes in guidelines and standard practices for treating chemotherapy side effects.

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Faster, smarter, more inclusive: The UK roadmap for cutting-edge clinical research

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The government update of August 2025 presents an ambitious and detailed plan to fundamentally transform the UK system for clinical research — supported by significant investments and structural reforms.

The focus is on three key changes:

- the transfer of research from hospital to outpatient community,

- the consistent use of digital innovations and

- the greater prioritization of prevention over treatment.

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Four strategic pillars guide these reforms:

-faster access to clinical trials,

- tackling major health challenges,

- reducing inequalities through inclusive research and

- creating a world-class environment for life sciences.

Special features of the roadmap include the annual investment of £1.6 billion for research through the National Institute for Health and Care Research (NIHR), with the NHS benefiting from significant financial returns, particularly in subsequent intervention studies. The new UK Clinical Research Delivery (UKCRD) program focuses on cross-sector collaboration, accelerated study setups (maximum 150 days) and promotes research offerings in primary and community care for wider participation.

A key part of the strategy is the Voluntary Branded Drug Pricing, Accessibility, and Growth Program (VPAG), which expands staffing capacity and creates new commercial research centres.

The following initiatives are particularly noteworthy:

- Improved study set-up plan: This “digital-first” approach removes unnecessary bureaucracy when approving studies; the results of the first two phases were already published in 2025. The results are continuously monitored.

- “Right Research, Right Setting” initiative: Research is located where patients receive their regular care — particularly in the community and primary care — to enable wider participation and more relevant insights.

- Proactive portfolio management: The active involvement of NIHR in industry (advisory group, optimised contract drafting) shows the shift towards partnership and early problem solving.

The update also describes progress beyond Lord O'Shaughnessy's recommendations: such as faster national contract value reviews (NCVR) for commercial studies, compliance with 60-day deadlines for regulatory approvals, the introduction of a clinical trial accelerator, and the publication of transparency data at site level.

In addition, the NHS consistently integrates research implementation into everyday working life — with new guidelines, targeted promotion of personnel development and initiatives to expand digital volunteer registers. As part of the “Be Part of Research” campaign, the government has set the new goal of reaching 2 million volunteer registrations by March 2026. Innovations in confidentiality agreements, pharmacy guidelines and optimised contracts are already reducing negotiation times and regulatory hurdles.

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Budget 2026: Opportunities for clinical research despite budget cuts?

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Despite the budget cut in the core budget, Germany continues to invest massively in research. The recently presented draft budget 2026 by Federal Finance Minister Lars Klingbeil sends mixed signals for the research landscape: While the section plan of the Federal Ministry of Research, Technology and Space (BMFTR), at 21.3 billion euros, is one billion lower than 2025 — and somewhat lower than 2024 — there are still strategic investment priorities.

Despite the nominal cut in the core budget, the Federal Government is focusing on strategic compensation: A total of 17.1 billion euros are earmarked for research and development in 2026, supplemented by Germany's High-Tech Agenda with 18 billion euros by 2029. “Research for seriously ill people and people with rare diseases” is being explicitly promoted. The 1,000 heads plus program to attract international scientists is supported with over 600 million euros in this legislative period.

Despite budget consolidation, there are still opportunities for our clients: The focus remains on targeted promotion of medical innovation and evidence-based therapeutic approaches even in difficult times.

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The whole team is delighted that our customer Smoke Free 23, whose path to the BfArM DIGA directory we have accompanied with a study lasting several years, has finally made it onto the list! Our smoke-free study with participants from all over Germany was the first of its kind to take place decentrally and completely digitally. The great effort and hard work are now paying off and we are proud of our customer, who persevered despite many unforeseeable hurdles and did not give up until the last participant was evaluated.

For us, this result proves that we have done a lot of things right, of which we are very proud. The experience we have gained in setting up this novel study will help us to pave the way for many more customers to join the DIGA directory in the future.

We wish Smoke Free 23 all the best and thank you for the great and fruitful collaboration.

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Crises as a catalyst for humanity: Thoughts from an entrepreneur

As I flipped through the latest economic forecasts for 2025 this week — geopolitical uncertainties, trade conflicts, structural challenges — I had an idea that Carel van Schaik would probably have formulated as follows:”We live in a state of emergency, but that is not our fate.”

The familiar uncertainty

The parallels between the current global economic situation and the COVID-19 pandemic are striking. Then as now, we face complex, systemic challenges that shake our usual structures. Back then, it was interrupted supply chains, lockdowns and a historic economic slump of 4.9 percent. Today, it is US tariffs, geopolitical tensions and a German economy that is barely stagnating.

But what concerns me the most as an entrepreneur is not the crisis itself — it is the reaction of people in my company to it.

The evolutionary heritage within us

Van Schaik would say:”Cooperation was the only life insurance we had.”

This primal human capacity for cooperation — which has kept us alive as a species for over 99 percent of our history — is just in its purest form.

During the pandemic, I saw my team spontaneously develop digital solutions, share workplaces, and take care of colleagues who were in quarantine. Today, in the face of economic uncertainty, I see the same willingness to cooperate: people who go beyond their job descriptions, take on responsibility and seek solutions together.

I'm proud of the people I get to work with!

The current economic challenges will pass as the pandemic has passed. What remains is the recognition that we are only as strong as our weakest link, but together we are stronger than any crisis.

At a time when 90 percent of people feel that our society is divided, the answer does not lie in more optimization or resilience training. It lies in a conscious return to what makes us human: listening, withstanding other opinions, empathizing, negotiating bold solutions together.

That is community spirit. That is being human. And that's our biggest opportunity.

As an entrepreneur, I see it as my task to create spaces in which these primal human abilities can flourish. After all, it is not algorithms or strategies that get us through crises — it is people and their innate ability to cooperate.

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On Thursday, July 24, 2025, as part of the Red Town Hall, the 17th Berlin Science Prize awarded. The Governing Mayor of Berlin, Kai Wegner, honored outstanding scientific achievements that significantly contribute to the excellence and innovative capacity of Berlin as a center of science.

The personally invited guests included Dr. Caroline Schmidt-Lucke, who, together with numerous representatives from science, politics and business, took part in the award ceremony and the subsequent reception. The event was a special opportunity to recognize the importance of research and innovation for the future viability of the capital.

The one with Main prize endowed with 40,000 euros was awarded to an institution whose work has set groundbreaking impulses for Berlin's scientific landscape. In addition, the Young Talent Award in the amount of 10,000 euros awarded to a young scientist under 35 years of age who further strengthens Berlin's profile as a science hub with innovative ideas.

This year's award ceremony once again underlined the diversity and international appeal of Berlin's research. Following the award, the guests took advantage of the opportunity to exchange ideas and network at a festive reception.

We warmly congratulate all prize winners and are impressed by their outstanding commitment to science and innovation in Berlin!

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