Product design for medical devices
At Custom Medical, we offer comprehensive product design support for medical devices. Our process begins with thorough field studies and competitive analysis to understand user needs and analyze the market. Based on these findings, we work closely with you to develop a customized design and innovation strategy that is both functional and aesthetically pleasing.
In addition, our product design offering offers even more holistic support. We integrate functional and aesthetic aspects and consider ergonomic factors, material selection, production processes, and costs. Our aim is to help you develop a medical device that is not only safe and user-friendly but also successful on the market.
Our expertise
Designers with awards
Our designers have been honored several times for their outstanding work and have won five Red Dot Design Awards, among others.
UX and product design from a single source
We offer you a seamless combination of UX and product design for comprehensive product concepts.
Comprehensive support
In addition to front-end development, we support you throughout the entire usability engineering process and with market authorization in Europe and the USA.
What we can do for you
Developing a product idea
We develop your technical product idea, identify the target group, and create suitable design approaches.
Documentation and tracking
Careful documentation of the design process, changes, and decisions is essential to fulfill regulatory requirements and ensure a smooth approval process.
Validation and verification
The design is verified through extensive testing and validation processes to ensure that it fulfills its intended purpose and meets the requirements of users and regulatory authorities.
Complex products
We are passionate about developing detailed utilization concepts from good ideas. Through good design, we turn complex technical products into outstanding user experiences.
Do you have a specific project you would like us to help you with?
You can get to know us in a initial consultation with our experts.
How we take care of the product design of your medical device
01
Kick-off
During our kick-off, whether online or in an on-site workshop, we aim to understand the project’s intention, approach, and expectations. We agree on a timeline, define feedback loops and milestones, and determine the tools for effective collaboration.
02
Field studies, research and competition analysis
In our field study and competitive analysis, we conduct interviews and research to understand the user needs and expectations of the target groups, broaden their horizons, and open up room for maneuver. The insights gained are then harmonized with your specifications. We work with you to prioritize and focus the product design to ensure that the end product meets the users’ needs and positions itself successfully on the market.
03
Ideation
In our product vision workshop, we capture the product’s basic aesthetic requirements and develop an understanding of its capabilities. In doing so, we identify unique selling points (USPs) and conceptualize business models that build on these strengths. We guide the entire ideation process, gather input to understand where the product should go, and develop a large pool of ideas and variants from which we then pursue the most promising ones.
04
Product design concept
When creating a product design concept, we sketch ideas and build on simple CAD models to quickly visualize different concepts. We quickly analyze different shapes, proportions, and effects to capture a variety of possibilities. We aim to capture ideas and thus create a basis for further product development. The resulting product concept defines the core idea and the basic functionality and serves as the basis for the further phases of detailed development.
05
Concept modelling
In concept modeling, we build the first physical surface models from simple CAD data to check the concept ergonomically or proportionally. Strengths and weaknesses can be quickly identified and the concept optimized. The models can be printed on our 3D printers and used for formative user testing.
06
Test of the concept model
To do this, we create screeners and recruit test participants to ensure a representative sample. We develop a test guideline that focuses on the user’s interaction with the product, e.g., the purely subjective perception of haptics and handling or the technical functions or processes. Tests are documented through video recordings, streaming observations, or direct observations on-site.
07
Detailing and finalising the product design
The resulting design concept is worked out in detail. The usability and ergonomics concepts are adapted and further developed based on the findings from the tests. The product’s components are designed in 3D, and their production technology is defined; a parts and assembly concept is created. The materials and surface finish to be used are defined, and the color concept is developed and implemented in product graphics.
08
Reporting results
When submitting the results, we create a product presentation that emphasizes the product’s most important aspects and features and provides you with 3D data about your product. In addition, we create photorealistic 2D renderings to give you a clear idea of the final product.
09
Authorisation and PMS at a glance
We always keep an eye on marketing authorization and provide support with summative evaluation and downstream post-market surveillance (PMS). We help to get the product through the summative evaluation processes and prepare the necessary documentation to fulfill the approval requirements. We also offer support in conducting the PMS and accompany the entire process to ensure that the product continuously fulfills regulatory requirements and that user safety is guaranteed.
We want to get to know you and your product!
