Through hard work and a strategic mindset, we help our clients succeed with their medtech projects. View some of our real-life cases in the videos below.
How we help our clients
Clinical study design on a drug-device product
In this case, we helped our client to significantly reduce time and costs for their clinical study. In collaboration with the client, we tailored the clinical design to conduct one clinical study instead of two; one for medical device and one for drug.
An in-vitro device strategy
The critical product-specific decisions in this in-vitro device case had a great impact on the market access strategy. This included the pricing, reimbursement and customer experience.
Regulatory Pathways that Reduces Costs
Choosing regulatory pathways can be as difficult as it is important. We helped our client to get a binding a FDA-approval as well as streamlining the regulatory process.
Solutions for borderline products
A borderline product is a product that can be defined as both a medical device and drug/substance. Minor changes in the product claims can make all the difference.