Strategic Medical Device Design & Development
For more than 60 years, Milani has supported companies in medtech, diagnostics and healthcare with strategic product design in the development of complex medical devices, from product strategy and medical product design to industrial design, usability engineering and UX/UI for connected devices and digital applications.
Our integrated design approach brings together user needs, technical feasibility, regulatory requirements and brand strategy, creating clarity early in the development process and resulting in safe, intuitive products with clear market differentiation.
Medical Design as a Strategic Tool
In medical and diagnostic technology, design is not something that happens at the end of a project, it starts at the beginning. Whether in hospitals, laboratories, or home care environments, requirements for hygiene, usability, safety, and seamless integration into existing workflows continue to increase. Those who structure and manage this complexity effectively create clear differentiation in the market.
Milani combines deep regulatory expertise with consistently user-centered design and a strong understanding of brand and positioning. We translate your business strategy into a clear, recognizable product language.
With decades of experience, we act as a strategic sparring partner in developing design solutions that bring together safety, usability, and formal clarity, many of them internationally recognized. Our processes are structured and efficient, with defined milestones and tangible outcomes, always focused on time-to-market and design-to-cost.
In addition to industrial design, we develop intuitive UX/UI solutions for connected systems, from embedded interfaces to digital applications.
Medical Product Design and UX/UI conceived as one system
Alongside Industrial Design, Milani develops intuitive UX/UI solutions for connected systems, from embedded interfaces to digital applications. With our integrated design approach, we align interaction logic, physical interactions and digital interfaces. This close integration creates a consistent user experience across device and interface. We structure complex functions and workflows so they remain clear and intuitive for users, while safety-critical interactions are clearly guided. At the same time, we ensure that the brand identity remains consistent across form, haptics and digital interaction.
Through close collaboration between Industrial Design and UX/UI, we reduce interfaces between disciplines and create clarity early on when making decisions about interaction concepts, product architecture and interfaces. This facilitates coordination throughout the project and helps avoid costly iterations later in development.
For Accelerated Medical Device Development
Our User-Centered Design Approach and Usability Engineering
Early assumptions can have a significant impact on the later costs of a project. For this reason, Milani makes concepts testable at an early stage and consistently aligns products with real-world use scenarios, from the initial idea through validation to market implementation.
Interviews, ethnographic research, and hands-on testing form the basis for clear design decisions. We systematically analyze user needs and specific requirements and translate them directly into architecture and interaction concepts. Through iterative prototyping, we validate concepts early and test workflows together with medical professionals, technicians and patients. You gain reliable decision-making foundations, reduce development risks, and accelerate time-to-market.
Formative and summative testing are integral parts of our process. The results are transparently documented and coordinated closely with R&D, Regulatory, and Product Management. We consistently incorporate MDR, FDA, and IEC 62366 requirements into the design process.
Beyond the product itself, we support companies in developing new offerings within the usage context, including training concepts, repair and service models, and additional patient-focused services. We connect product, usage, and service in a structured way, developing solutions that convince physicians, nursing staff, and patients alike.
User-Centered Solutions for MDR Compliance
Usability Engineering for Medical Devices
We integrate usability engineering early in the product development process and support the implementation of MDR and IEC 62366-1 requirements in close collaboration with your development team.
Regulatory Compliant. Economically Viable.
Ecodesign and Circular Design in Medical Technology
As EU regulations continue to evolve, integrating product sustainability into development in a structured way is becoming increasingly important, particularly in medical technology, where development cycles are long and validation efforts are significant. Regulations such as the Ecodesign for Sustainable Products Regulation (ESPR) and the Packaging and Packaging Waste Regulation (PPWR) are gradually reshaping the framework for manufacturers. At the same time, credible sustainability documentation is increasingly expected throughout the supply chain and in procurement processes.
Even if your company is not yet directly affected, early integration of product sustainability strengthens your market position and provides strategic stability for long-term, resilient product platforms.
Milani supports you in embedding ecodesign and circularity requirements into architectural and specification decisions from the outset. We assess where your product or portfolio is impacted, identify the relevant leverage points, and translate them into solutions that are technically feasible, regulatory compliant, and economically viable.
Furthermore, we see the circular economy as a driver of innovation. We support companies in designing products and product architectures specifically for reuse, refurbishment, repair and recycling. At the same time, we work with our clients to develop the corresponding take-back, service and business models and support their economically viable integration into existing organizational structures.
Experience in Medical Design across a wide range of MedTech applications
From ventilators and ophthalmic diagnostic systems to breast pumps and dental devices, Milani has developed medical devices for a wide range of clinical and home-use contexts. This experience spans application areas including:
- Emergency and respiratory care devices
- Diagnostic and monitoring systems
- Ophthalmic and optometric products
- Sterilization equipment
- Cardiothoracic surgery and wound care solutions
- Laboratory and diagnostic instruments
- Hearing aids and audiology devices
- Surgical and medical instruments
- Femtech innovations
- Dental equipment
- Single-use medical products
LET'S TALK
Looking to create innovative, user-centered, and future-proof medical devices? Let’s discuss how Milani can support you.
Example Projects Medical Design
For more than 60 years, Milani has been developing design that reflects the brand's values, optimizes highly specialized processes in medical technology, and inspires doctors, nurses, and patients alike. Be inspired by our projects.
Questions and Answers
As early as possible. Decisions about product architecture, interaction concepts, user guidance and product language are made in the early stages of development. Involving design early helps ensure that user needs, technical requirements and regulatory requirements are considered from the outset and can help avoid later modifications. Sustainability also needs to be considered early so that product architecture, material choices, construction and potential future business models can be developed in an economically viable way. This is why Milani works with an integrated design approach that considers these factors together throughout the development process.
Milani supports companies from product strategy and concept development through medical product design and industrial design to UX/UI and usability engineering. We take on specific tasks or support the design process across multiple stages of development.
Yes. Our industrial design and UX/UI teams develop the device and interface together. Physical interaction, digital user guidance, embedded interfaces and applications are coordinated to work together effectively in use.
Usability engineering is part of the design process from the outset. Through user research, prototypes, and formative and summative testing, we evaluate interaction concepts early and integrate the requirements of IEC 62366-1 as well as relevant MDR and FDA requirements into the development process.
Milani works directly with our clients’ specialist teams. Insights from research, prototyping and usability testing are continuously coordinated with R&D, product management and Regulatory Affairs. This allows design decisions to be aligned with technical, regulatory and commercial requirements early in the process.
Yes. In addition to individual medical devices, Milani develops overarching design strategies, product design languages and platform concepts. This enables new products to be integrated into existing portfolios and product families to be strategically developed across multiple generations.
Milani has been developing products for MedTech, diagnostics and healthcare for over 60 years, from ventilation and diagnostic systems to surgical, ophthalmic and sterilisation equipment. We are experienced in bringing together ergonomics, usability and technical requirements in complex and safety-critical medical devices.
This experience is also built on long-standing design partnerships with MedTech companies. We have completed more than 100 projects with Dräger alone, and Milani has been working with Medela for decades.