Medical Product Development

Medical devices that are regulatory safe, intuitive to use, and brand-shaping.

We combine Usability Engineering, UX Design, and Engineering into comprehensive medical technology development – for products that pass regulatory standards and impress in the market.

Usability is not optional, it is mandatory. Since MDR 2017/745/EU, proof of usability is a regulatory requirement for all medical devices – and at the same time one of the strongest levers for your market success.

Schedule a consultation Graphic on the topic of Usability Engineering

Infographic depicting issues with medical device design: complex requirements, poor usability, costly late problem detection, and engineering-UX gap.

Challenge

Why many medical devices fail

Complex regulatory requirements (MDR, Usability, Risk Management)
High error risks due to poor operating concepts
Late usability problems → expensive iterations
Gap between engineering and UX

→ We systematically solve precisely these interface problems.

Our Method

Medical 720° -
Two Perspectives, One Goal

Our MedTech development combines from the beginning:

UI/UX Design for intuitive operation
Engineering for technical and production-compliant implementation

The result: safe, ergonomic and brand-consistent medical devices from a single source.

fewer iterations
faster validation
reduced development risks
better time-to-market

Infographic with four sections: User Interface Concept, Screen Design, Ergonomics, User Testing.

Design Control Process

Safe through every exam

Our Design Control Process covers all regulatory requirements whilst incorporating a human-centred design approach – resulting in products that win over inspectors and delight users.

Definition of clear product requirements
Establishing user needs, specifications, and regulatory requirements
Risk management throughout the entire development process
Identification, assessment, and minimization of potential risks
Verification & Validation
Proof that the product functions technically correctly and meets user requirements
Documentation & Traceability
Complete documentation of all development, testing, and change processes

We combine the Design Control Process with Human Centered Design for optimal results.

Our development process

Flowchart with 7 phases: Analyze, Concept, Design, Prototyping, Usability Testing, Validation, and Production Transfer, with icons.

Usability Engineering according to DIN EN 62366-1

Usability is not an add-on but a regulatory requirement – and our core focus.

Our Services

User analysis & context definition
Use-error analysis & risk derivation
Formative tests
Summative validation
Documentation for approval

Our Result

→ reduced error rates
→ safe operation
→ higher acceptance

Working together for success – with our expertise in medical product development, we can take your project to the next level. Have we sparked your interest?

Service Spectrum

NEW PRODUCTS

Development

Concept & Design
User Interface & UX
Engineering & Prototyping
Validation & Testing

EXISTING PRODUCTS

Optimization

UX/Usability audit
Redesign under regulatory requirements
Error reduction & safety improvement

GENERAL

Approval Support

Usability engineering file
Risk analysis
Test design & implementation

EXISTING PRODUCTS

UX Check

Identification of weaknesses and optimization potential
Quick results without extensive user studies
Concrete recommendations for sustainable improvement of user experience

More about UX Check

Discover all services

Usability Testing

Our approach to testing can be divided into four parts.

Request a usability test

Planning & Use Specification

Define user groups, application context, scenarios, specify requirements

Planning & Use Specification

Define user groups, application context, scenarios, specify requirements

Prototyping

Hardware simulation and digital click dummies, microcontrollers, encoders & standard control elements

Prototyping

Hardware simulation and digital click dummies, microcontrollers, encoders & standard control elements

Usability Tests

Iterative and formative tests, early detection of vulnerabilities, interviews, questionnaires

Usability Tests

Iterative and formative tests, early detection of vulnerabilities, interviews, questionnaires

Summative Validation

Proof of usability for approval

Summative Validation

Proof of usability for approval

References

Man operates Ivoclar PM7 CNC milling machine

Pentero surgical microscope in the background tables with formulas in the dark

Working together for success – with our expertise in medical product development, we’ll take your project to the next level. Have we sparked your interest?

Get in touch now

Connected services

UI/UX Design

Engineering

Product design

Your contact person

Evamaria Plehn, Head of UI/UX Design

Our expertise is not only proven by 400+ awards, but also by the enthusiasm of our customers.

Product DesignEngineering

Calistair

"We were particularly impressed by the enthusiasm and technical creativity of the Busse employees. The atmosphere in the project was characterized by professional looseness and great agility. We turned an idea into a finished product in 4 months!"

Product DesignEngineering

Thyssenkrupp

"As an experienced design partner, BUSSE offers everything from a single source. Creative design solutions, prototyping through to small series production and UX design for software. The solution approaches and methods through to implementation always lead to a result that perfectly meets the requirements."

Product DesignEngineeringPrototyping

Sigel

„The collaboration with the entire project team was always goal-oriented, constructive and pleasant in terms of communication. Mr. Timm and his project team always kept the functional and safety requirements in mind and understood what is also important to us in product development: can-do mentality, agile mindset as well as flexibility and efficiency in all project situations."

UI/UX Design

Prinoth

„BUSSE is our design game-changer for snow groomers! Their UI/UX team elevates not only icons and layout but the entire user experience to a new level. Clear operation turns every ride into a pleasure. Reliable from development to series production, BUSSE is by our side. Their interface, based on precise product research, simplifies operation. Flexible, forward-thinking, and reliable – BUSSE is our satisfaction guarantee!"

Product Design

Mikron

"With BUSSE as a sparring partner, we were able to successfully work out a brand-defining design for our latest products that was appropriate for the target group. BUSSE understood our internal company processes very well and was therefore able to deliver optimal results. Deadlines were always met, you can rely on BUSSE. Anytime again!"

Product DesignEngineering

Keller

"We were positively surprised by the collaboration with BUSSE in that the focus was not solely on the appearance of our product, but rather on the interplay of economical manufacturing solutions, optimized ergonomics and a functional design. The result now impresses with a coherent, unprecedented design concept."

Product DesignEngineering

Britax Römer

„Child seats are not only visually complex but also technically demanding. Our longstanding partnership with BUSSE turns development into a creative experience. Design sprints and a versatile selection matrix relieve engineers, minimize time-consuming iterations. We appreciate BUSSE for their timely implementations despite limited resources. The collaboration is not only effective but also truly enjoyable!"

Product DesignEngineeringPrototyping

Infinite Running

„What impressed me right from the start was the incorporation of many innovative ideas that led to a result that is now ready for the market. Despite patented hurdles, design concepts were fine-tuned and refined until a turnkey concept for prototypes and a near-series maturity was achieved."

Product DesignEngineeringPrototyping

Hammer

"BUSSE has been the perfect partner for us to develop new and innovative ideas for over fifteen years. BUSSE offers a very high level of professionalism and a first-class understanding of the brand. The team has completely internalized the high standards of our projects and with exceptional creativity, as well as full dedication, has helped us to set new trends. Many of our bestsellers bear BUSSE hallmarks."

Product Design

Darda

„From the outset, BUSSE embraced our technical wishes and constraints, weaving them into a cohesive product. Their craftsmanship is impressive, making the collaboration not only enjoyable but also an inspiring process due to their expertise. It's a partnership that seamlessly blends creativity with professionalism."