For medical and IVD medical device manufacturers credibility and proof of benefit are crucial. It is easy to claim that a device is better than the competition, but true conviction comes from scientific evidence.
Let's work together to position your devices optimally and set them apart from the competition. We support you in backing up your marketing claims with compelling studies to convince customers and cost-bearers.
Our marketing claim studies not only provide you with scientific credibility but also enable you to use the output for publications and advertising. This simplifies negotiations with health insurance companies, hospitals, and laboratories and increases sales of your devices.
You benefit from first-class expertise in usability, marketing claims, and scientific methodology with us. You can be sure that you will receive reliable outputs quickly and within your budget.
Our team of experts will create a well-founded study design for you, determine methods and test scenarios, and define the test group for objective usability evidence.
To make your day-to-day project work easier, we take over the recruitment of all test subjects as well as the entire organization of consent and non-disclosure agreements and remuneration.
To ensure realistic test scenarios, we provide sufficiently representative use environments in Germany and other countries, whether in the doctor's room, ward, or operating theater.
Our experts carry out the project according to plan, collect raw data, and create a scientific basis for objective evidence – with precise documentation for maximum traceability.
Our statistical analysis of the raw data provides reliable results, summarized in a detailed report. Use this as a basis for white papers, scientific publications, or advertising materials.
We offer professional consultation in all phases if you want to conduct the study yourself. Benefit from our scientific know-how to avoid mistakes and achieve your study goal efficiently.
Contact us to develop the best strategy for proving the benefits of your device together.
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We help you accelerate the development and approval of your devices through our formative evaluations.
We help you create the prerequisites for the rapid approval of your devices with IEC 62366-1 and FDA compliant summative evaluations.
With our usability labs in Germany and the USA, you create all the prerequisites for successful usability studies and usability tests.
We take over the complete recruitment of healthcare professionals for your usability studies – from search to support on the day of the test.
Need a standard-compliant usability file (human factors engineering file) to pass audits and approvals? We have the know-how! Our customized templates and professional support make it possible.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
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