Our End‑to‑End Process – Modular. Individualized. Built for Pharma & Medtech.
At Evoleen, we help you move from challenge to market-ready solution—faster, smarter, and always tailored to your needs.
Our modular end‑to‑end process gives you exactly what you need, when you need it. Whether you’re looking to solve a single challenge or drive an entire innovation pipeline, we’re with you every step of the way.
We partner with leading pharma and medtech companies to understand their toughest challenges, co‑create solutions, and bring them to market at speed—without the rigid constraints of traditional corporate structures.
Solving Your Challenge: Assessment & Ideation
We start where it matters most: with your challenge.
Our experts dive deep into your indications, markets, and pain points to uncover what’s truly worth solving.
✔ Deep dives into customer challenges & market needs
✔ Ideation, co‑creation & rapid prototyping—from proof‑of‑concepts to front‑end projects with engineering & software development
✔ Holistic project management across the entire lifecycle
We’ve partnered with 30+ leading pharma & medtech companies to generate tailored data & market insights through our extensive network of patients & healthcare professionals.
Together, we tackle challenges across the therapy lifecycle, such as:
Streamlining patient identification
Optimizing stratification & endpoints
Enhancing diagnosis & treatment decisions
Improving adherence & engagement
Managing side effects & reducing dropout rates
Drive innovation beyond corporate constraints.
Our small, agile teams of health experts help you ideate, validate, and certify new solutions—delivering them to market at maximum speed & reasonable cost.
Evoleen Technology
From Concept to Scalable Digital & Device Solutions
Once we know what to build, we help you build it—right.
✔ Deep technology expertise: hardware, software, and AI/data science
✔ Online & mobile platforms: front‑end, back‑end, and secure HCP cloud infrastructures
✔ Software as a Medical Device (SaMD) and smart device development
✔ AI & predictive models: machine learning, data analytics, user‑friendly dashboards
✔ UI/UX design & testing: intuitive, beautiful, and efficient experiences
✔ Agile development: iterative sprints, sprint reviews, and transparent prioritization
✔ IP support & tech stack maintenance
We work pragmatically—with short, focused meetings and frank, constructive feedback.
Our designers create wireframes, interactive prototypes, and conduct usability tests so you can see and refine your product early—long before development locks in.
Result: Solutions that are technically robust, regulatory-ready, and loved by users.
Evoleen Access
Regulatory, Quality & Market Pathways
You focus on your product—we take care of the rest.
✔ Regulatory: Global strategy, authority interactions, and compliant documentation
✔ Quality: QMS implementation (ISO 13485, GDPR), audits, and agile-compliant processes
✔ Clinical: Development strategy, submissions to authorities and IRBs
✔ Development Processes: MDR/FDA‑aligned agile software development
✔ Reimbursement: DIGA and other programs—dossier preparation, submissions, authority interactions
We enable you to navigate complexity and unlock sustainable business models by ensuring regulatory compliance and reimbursement readiness from day one.
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
- Research Report
- Concept idea
- Business case
- Competitive overview
- Go-to-market approach
- clinical validation strategy
- regulatory requirements
- governance model & 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 & clickable prototypes
- Test customer & 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 & 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
All Under One Roof – Your Partner for Innovation
At Evoleen, these services are not isolated offerings—they are interconnected building blocks of one mission:
to help you turn bold ideas into certified, market‑ready health solutions.
Whether you need deep market insights, 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.