Introduction
The world of medical devices is constantly evolving, with new requirements being added from all sides. This applies especially to the user interface and design of medical devices.
In terms of regulation, usability has become more of a focus in recent years. The user experience and the design of the housing have also become crucial. This is particularly true for medical devices used by laypeople or doctors in their own practices.
But how do you reconcile all these (design) requirements and create an outstanding medical device? The answer is simple: with the right design partner. Here are 10 reasons why you should work with us:
1. Expertise and Experience
Our team has decades of experience in medical device design and regulatory affairs. We have the knowledge and ability to handle even the most complex projects. Our references include a wide range of successful medical products, from digital applications to heart-lung machines.
For instance, consider our work on the groundbreaking cerebral blood flow measurement device for premature infants NeoDoppler. This project required advanced technical skills and a deep understanding of the usability and user experience of the users (health care professionals and parents). By conducting extensive user research and iterating on the design based on real user feedback, we designed a device that is not only effective but also user-friendly.
2. Product Strategy and Market Placement
We are more than just an execution force; we partner with you to make your product successful. We analyze current market solutions, interview users worldwide, and identify your product’s strengths. By understanding user needs and market trends, we help you position your product effectively.
For example, during the development of a new surgical tool, we conducted detailed market analysis and competitive benchmarking. We discovered gaps in the market where existing tools failed to meet surgeons’ needs. By interviewing surgeons and observing surgeries, we identified specific pain points and opportunities for improvement. This comprehensive strategy enabled us to design a tool that not only filled these gaps but also provided significant advantages over competitors, ensuring successful product placement.
3. User-Centered Design
We place the user—whether patients or healthcare professionals—at the center of design development. By incorporating user feedback early in the product idea stage, we ensure the right product is developed from the start. This user-centered approach enhances usability and user experience, leading to increased satisfaction and better sales figures.
For instance, in the creation of a new insulin pump, we involved both patients and healthcare providers from the very beginning. Through focus groups, surveys, and usability testing, we gathered invaluable insights that shaped the design. We learned about the daily challenges patients face and what features would make the pump easier to use. This input directly influenced the design, resulting in a product that was not only intuitive but also improved adherence to treatment, ultimately benefiting patient health. You can find the case study for the corresponding app here.
4. Regulatory Compliance
We offer much more than “just” design. We take a pragmatic approach to regulatory compliance every step of the way. We conduct all formative and summative evaluations/human factors validations internationally and can create the complete usability engineering file on request. Our comprehensive approach ensures your product meets all regulatory requirements, making the approval process smoother and faster.
One example project is the conduction of a formative and a summative evaluation together with fasciotens. In this project we simulated an open abdominal wall defect in our Medical Usability Lab to be able to generate methodically clean results.
5. Flexible Design Services
Whether you’re a start-up needing help defining your corporate colors for the first time or an established corporation with a corporate identity and component library, we adapt to your needs. For start-ups, we help select the right colors and build a strong brand identity. For established companies, we optimize existing products within the given framework.
We recently worked on a project to develop a skin cancer screening app from scratch. This project required the full package; from brand development to user interface design. We started by defining the brand colors and overall visual identity. Then we worked on the user interface of the device, making sure it was intuitive and appealing.
6. Award-Winning Design
We have won numerous design awards with our customers, including the prestigious Red Dot Award Winner in the User Interface Design category five times in a row. Our award-winning design is a testament to our commitment to excellence. By working with us, you can be confident that you will receive outstanding design that stands out in the market.
One of our notable successes was an application developed with OTH to support patients with chronic conditions. OTH’s Clinician Portal enables healthcare professionals to quickly access and interpret key patient data. The design is modern, clean and loved by OTH and users. It is nominated for the German Design Award 2025 and won the Red Dot Award User Interface 2023.
7. International Reach
Our locations in Darmstadt (EU, Germany) and Boston (USA) enable us to cover applicable regulations for the usability of medical devices worldwide. We have conducted formative and summative evaluations/human factors validations globally, ensuring you are optimally equipped to obtain international approval for your product.
We have several examples where we have worked to meet regulations around the world. One example is the development of a new heart-lung machine together with LivaNova. In this project we helped with the summative evaluation / human factor validation in Europe and the USA. In addition, we supported the documentation process.
8. Cost-Efficient and Flexible Billing
We understand that different project phases have different requirements. That’s why we offer flexible billing models to get the best results for you. You can choose from fixed price offers, hourly rates, or our innovative medical design flat rate, where you pay a fixed monthly amount for as much design as you need.
For instance, a client developing a new diagnostic tool required ongoing design support throughout various stages of the project. Our flexible billing model allowed them to switch between hourly rates and fixed priced packages based on their needs at different times. This adaptability ensured they received consistent, high-quality support without exceeding their budget, ultimately leading to a successful product launch.
9. Collaborative Process
The best products are created when everyone involved contributes their expertise. We actively involve you and your stakeholders in the design process, defining the mode for this—including all approval loops—directly in the kick-off. We integrate your other service providers, such as development partners, ensuring everyone is involved and can work excellently together.
In one instance, we worked with a client developing a complex surgical instrument. By involving surgeons, nurses, and biomedical engineers in the design process, we ensured that all perspectives were considered. Regular workshops and feedback sessions helped us refine the design continuously, resulting in a product that not only met but exceeded user expectations.
10. High Customer Satisfaction
We measure our success by our customers’ satisfaction using the Net Promoter Score. We ask every customer the same question after every project: “On a scale from 0 (extremely unlikely) to 10 (extremely likely), how likely is it that you would recommend us to others?” Our customers give us an average rating of 9.4 (as of July 2024). This high level of satisfaction reflects our commitment to excellence and our ability to deliver outstanding results consistently.
Conclusion
Choosing the right partner for your medical device can make the difference between a successful and unsuccessful product. We offer everything you need to make your medical device a success, from expertise and experience to flexible design services and high customer satisfaction.
We would love to get to know you and help you bring your product to success. We look forward to hearing from you.
