As shown in the graph above, only 31% of all 510(k) applications (Premarket Notifications) goes through the approval process without a request for ‘Additional Information’ (AI) from the US approval authority; U. S. Food and Drug Administration (FDA). This figure clarifies and emphasizes the bureaucratic and often confusing approval process that all medical devices must […]
A thought-provoking feature we recommend reading is this (Danish) piece from Ingeniøren. Technology is not something to be afraid of, even if you do not understand it. Think of what technology has done throughout human history. It is the very foundation of our development and it will continue to be. Those able to handle the technology […]
We recommend reading this article from The Economist. It has an interesting perspective. But we have a few comments from our side of the fence where we develop healthcare innovation in collaboration with both big pharma and start-ups. It is naive to think that the healthcare industry is falling behind because they haven’t yet […]
We have all had them in our hands. Long reports and internal documents stuffed with stock phrases, numbers, percentages, lines of reasoning and disclaimers. Documents that tempts us to only skim the executive summary because reading the whole thing will occupy us for several hours, and because we know that we will not even be […]
We live in a knowledge society where knowledge is generated, processed, shared and made available to all members of society, at all times. According to David Derbyshire “Scientists have worked out exactly how much data is sent to a typical person in the course of a year – the equivalent of every person in the […]
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 […]