Compliance & Safety Revolutionizing the diagnosis and care of cancer - Case NeoDynamics Compliance & Safety Innovation & New Technologies A Swedish MedTech company, NeoDynamics, is transforming the diagnosis and care of cancer with its newly-launched biopsy system, NeoNavia. For a company that started its journey as a small startup, a close collaboration with an experienced partner has paved the way for achieving significant milestones. Share this story: Every day, 20 to 25 women receive a breast cancer diagnosis in Sweden. The total amount of breast cancer diagnoses made each year in Sweden is more than 8,000. Diagnoses are achieved using physical exam, visualization tools and through the analysis of different types of biopsies, i.e. tissues samples. Taking these tissue samples still involves certain problems and risks. NeoDynamics AB, a Swedish MedTech company dedicated to improving the diagnosis and treatment of cancer, has invented a more controlled method for taking tissue samples. With the new method, sampling is made easy regardless of complex positioning or tissue characteristics, and sometimes samples that are acquired through surgery today can be obtained earlier in the process. This supports a better planned personalized treatment process, which results in better patient outcome and from a payer perspective, more cost-effective care. Starting the journey The discovery and diagnosis of cancer at an early stage is crucial for saving lives. This was the premise that NeoDynamics was founded on. In 2012, the company was aiming to take the next step towards an actual product. However, for a small startup, hiring all the experts required to develop a MedTech device from start to finish would have been extremely expensive. NeoDynamics needed a partner with the right competence and a certified quality management system. Due to its expertise in medical technology, regulatory requirements, and the certified development process, Etteplan got the job. “Our core competence is our medical technology innovation and our understanding of how it can improve diagnostics within breast cancer and beyond. We don’t need to become the best of the best at product development; it is too expensive and time consuming to build up a full R&D unit that understands the regulatory landscape of our product”, summarizes Magnus Olsen, CTO at NeoDynamics. Etteplan’s role in the product development project included the design and development of a ready-to-production biopsy device. Throughout the process, Etteplan also made sure that the device fulfilled the latest regulatory requirements and helped NeoDynamics with project management and technical documentation. The first version of NeoNavia was completed in 2016. Towards the wider use of better diagnostic methods In 2021, it was time for another big announcement. After 4 years of intensive work, a new, improved version of NeoNavia was launched. The new system, intended for ultrasonic guided biopsy, is built on an innovative patented pulse technology, based on research at the Karolinska Institutet in Sweden. The device is designed to offer optimal needle control and maximum tissue yield for accurate diagnosis and individualized treatment of breast cancer. “The launch of NeoNavia is a good example of how our engineering truly makes a difference”, says Mårten Jansson, Regional Manager at Etteplan Sweden. In September 2021, NeoDynamics announced it has received orders from four high profile clinics in Germany and Switzerland for NeoNavia (see press release here). Currently, the device is evaluated for diagnosis of breast cancer at leading clinics in Sweden, Germany and the UK with positive feedback. For more information, read our article "MedTech devices and connectivity – Mission impossible?"