Our End-to-End Approach. Modular. Individualized.
Solving Challenges
for Pharma:
We start with what matters most—your challenge.
Our experts dive deep to uncover what’s truly worth solving.
🔍 Deep dives into customer challenges and market needs
💡 Ideation, co‑creation, and rapid prototyping
🧩 Holistic project management across the entire lifecycle
Together we tackle challenges across the therapy lifecycle:
- Streamlining patient identification
- Optimizing stratification and endpoints
- Enhancing diagnosis and treatment decisions
- Improving adherence and engagement
- Managing side effects and reducing dropout rates
- Solving other in-market or innovation challenges where large corporations seek fresh ideas and the expertise of an agile health boutique firm
Solving Challenges
for Medtech:
We start with what matters most—your challenge.
Our experts dive deep to uncover what’s truly worth solving.
🔍 Deep dives into customer challenges and market needs
💡 Ideation, co‑creation, and rapid prototyping
🧩 Holistic project management across the entire lifecycle
Together with you, we tackle the following topics:
- Exploring market challenges and opportunities – understanding tasks, pains, gains through customer empathy work
- Assessing business opportunities through product pilots
- Solving innovation challenges where large corporations seek fresh ideas and the expertise of an agile health boutique firm
- Developing solutions in legal manufacturing set ups
Solving Challenges
for Governments:
We start with what matters most—your challenge.
Our experts dive deep to uncover what’s truly worth solving.
🔍 Deep dives into challenges and national health systems needs
💡 Ideation, co‑creation, and rapid prototyping
🧩 Holistic project management
Together with you, we tackle the following topics across model of care:
- Streamlining patient pathways
- Optimizing processes and workflows
- Enhancing diagnosis and treatment decisions
- Improving adherence and engagement
- Managing side effects and reducing dropout rates
- Solving other health care innovation challenges where governments seek fresh ideas and the expertise of an agile health boutique firm
Once we know what to build, we help you build it—right.
🛠️ Deep tech expertise: hardware, software, AI/data science
🌐 Frontend & backend platforms, secure HCP cloud setups
🧬 Software as a Medical Device (SaMD) & smart devices
📊 Predictive models using AI & machine learning
🎨 UI/UX design & usability testing
🔁 Agile development with iterative sprints
🧠💼 IP support & tech stack maintenance
Our Solutions include:
Digital therapeutics & diagnostics, Smart medical devices, Drug-device combinations, Patient engagement solutions, Blended care models, AI-supported data models
From Concept to scalable Digital & Device Solutions
You focus on your product—we handle the rest.
📋 Regulatory: Strategy, authority interactions, compliant documentation
✅ Quality: QMS (ISO 13485, GDPR), audits, agile processes
🧪 Clinical: Strategy, submissions, IRB coordination
🧰 Development: MDR/FDA-compliant agile processes
💶 Reimbursement: DIGA & other, dossiers, submissions
🇪🇺 EU Rep: Smooth EU market entry & MDR/IVDR compliance
We simplify complexity and ensure you’re ready for compliance, reimbursement, and growth from day one.
Regulatory, Quality & Market Pathways
All under ONE roof – Your Partner for Innovation
At Evoleen, our services are not isolated offerings—they are interconnected building blocks of one mission:
to help you turn bold ideas into market‑ready health solutions.
Whether you need deep market insights, innovative solutions, cutting‑edge technology development, or regulatory and access expertise,
we seamlessly connect these capabilities to deliver end‑to‑end value—tailored to your needs, at the speed the market demands.
Let’s solve your challenge together.
Why do partners collaborate with Evoleen?
1
100 % health focus
Evoleen is solely dedicated to challenges in Pharma & Medtech and the development of health solutions. This unwavering focus allows us to maintain a clear vision and minimize distractions.
Thanks to our end-2-end capabilities, we can combine all the necessary skills from assessing challenges, to strategy development, ideation, solution building, quality & regulatory, clinical evidence and commercialization.
2
Faster than in-house
Partners working with Evoleen are committed to driving innovation with agility and speed beyond their own organizations. They may lack specific expertise or want to complement their internal efforts with an external partner to accelerate innovation and solution development. For them, we are the ideal partner to help them think creatively and generate out-of-the-box solutions.
3
Skin in the game
We go far beyond the traditional role of service provider. We have a vested interest and are willing to share risks with pre-defined success fees. This demonstrates our commitment and dedication to the success of our partnerships.
4
Blending start-up and corporate expertise
Our experienced professionals bring the best of both worlds. They have extensive experience in large corporations, small and medium-sized enterprises (SMEs) and start-ups. This unique combination enables them to navigate the unique characteristics and dynamics of both environments.
The Evoleen team is driven by an exceptional entrepreneurial spirit and mindset.
5
Unique ecosystem
At Evoleen, everything needed to successfully develop digital health solutions and smart medical devices can be found in our comprehensive ecosystem. Our extensive network includes startups, healthcare experts, hospitals and more. This ecosystem provides unparalleled access and fosters cross-fertilization, creating a rich environment for collaboration.
How we work
Phase 1: Problem worth solving
Together with our partner, we explore a specific market and or therapy challenge, validate and shape first ideas that address the problem or need in the specific therapy space.
Goal
Identify and understand a problem. Find first ideas how to tackle the problem.
Methods
Kick-off workshop, customer empathy work, interviews, desk research, pains gains task analysis, first ideation. idea detailing, validation with interviews, design thinking and lean innovation method.
Our deliverables
Problem definition, concept idea, business case, business plan (incl. stakeholder analysis, competitive overview, business model canvas, go-to-market approach, etc.), clinical validation strategy, regulatory requirements, governance model and financing.
Duration
3-6 months with several core team members.
Phase 2: Ideation & Prototyping
We ideate, conceptualize the solution, develop first intuitive prototypes and test in real-world scenarios
Goal
Ideation
Develop first concept solutions and clickable prototypes
Test customer and stakeholder acceptance.
Methods
Idea detailing, first prototype testing – validation with interviews, customer empathy work. Leveraging the vast Evoleen ecosystem with direct access to patients & HCP’s
Our deliverables
Concept solution
First hardware prototypes
Clickable software prototypes
Test report
Duration
6 months
Phase 3: Solution Development
We cover all development stages for digital and hardware solutions and deliver a certified product.
Goal
Ensure clinical & market fit
Cover all R&D stages and deliver solution
Create venture / legal manufacturing set-up (optional)
Manage end-to-end certification
Methods
Iterative solution development according to the agile method
Our deliverables
Improved product
Market test reports
Legal manufacturing readiness
Certified product
Duration
22-30 months
Phase 5: Commercialization & Scale-up phase
We execute go to market or enable go to market if commercialization is managed by our partner
Goal
Market entry, adoption
Our deliverables
Go to market strategy
Go to market execution
Market feedback
Drive ramp-up & long-term growth
Lifecycle Management & Product improvement
Timing
indivual
Frequently asked quesitons
About a third of our cases are co-created with healthcare, life science, pharma and medtech companies that present us with a specific challenge. Another third come from university hospitals, healthcare professionals and healthcare providers. The rest comes from within our own team, because Evoleener are constantly scouting for new unsolved challenges in healthcare.
Sometimes our partners have already done an analysis and have a good understanding of the customer’s problems. Then we take over and drive the ideation and solution development with agility and speed. In most cases, however, we start with a joint discovery phase to understand the “problem – challenge” to be solved.
At Evoleen, we believe in the power of tailored collaboration models. Whether it’s understanding a specific problem, ideating solutions, developing rapid prototypes, market testing, legal manufacturing partnerships, we work closely with you to determine the ideal model that fits your budget and strategy. Our approach is driven by a single goal: to maximize your chances of success. We understand that every organization is different, and that’s why we work hand in hand with you to create the perfect setup that will propel you towards your goals and aspirations.
Unlike traditional models, we charge attractive hourly rates and share the risk through a disruptive fee-for-service and milestone-based pricing with success fees, aligning incentives for impact.
Your budget is unlimited?
Let’s talk ! We are happy to collaborate.
Your budget is limited? Let’s talk too! We have already achieved extraordinary results with minimal budgets.
“Evoleen offers the perfect solution for companies looking to build new businesses. They create a new business that is detached enough from the core business to thrive, but close enough to become part of it.”
“ ‘You cannot escape tomorrow's responsibility by avoiding it today’ is THE management approach to develop the future of digital healthcare. With Evoleen, we have found a reliable partner to design this future. ”
“Evoleen is pioneering the next generation of service excellence. Digital healthcare combined with entrepreneurship - a crisp and unique way to deliver true biomedical innovation.”