Marianne is an expert in quality systems – ISO9001, AS9100, the Medical Device Standard ISO13485, including the Special Design Control Process in Medical Device Development and has worked with quality systems in the last 15 years. Most recently for 10 years at Coloplast. Marianne has also worked extensively with validation – processes, clean rooms and […]
FORMLABS FORM 2 Throughout the years, people have often asked us why we do not own a 3D printer, presumably because these are marketed as an essential tool in product development. The truth is that we have been using 3D printed prototypes throughout the last decade, but having a printer at the office has never […]
We often see medical devices that fail to launch at the expected date, fail to reach sales goals and thereby ROI, or even fail to reach market launch all together. When diving into the reasons for this, data reveals that project scope, execution, and expectations are key factors. Also, new studies confirm our belief: […]
The design community has fully adopted Design Thinking as a tool for conducting rapid and efficient product innovation. At the heart of this lies the chief mantra “Fail fast, fail cheap, and fail early”, which is commonly used throughout the larger worlds of innovation and entrepreneurship. Unfortunately for businesses and entrepreneurs alike, embracing this mantra […]
THE IMPACTS OF A HIGH-SPEED PROJECT History has shown that reduced time-to-market has a huge impact on revenue. The expression “a day sooner is worth a million dollars” originates from the pharma industry and saw the light of day in the mid 1990’s. One of the most effective ways of reducing time-to-market is by embracing […]
IN THE BEGINNING OF 2014, AXLAB LAUNCHED A REVOLUTIONARY MEDICAL DEVICE FOR USE IN LABORATORIES AND CLINICS By using BiopSafe, one of the most common problems associated with handling a biopsy has been solved. The risk of being exposed to formalin has been eliminated. A risk that many doctors, veterinarians, laboratory technicians and nurses face […]