A Platform for Biopsies
Knowing well that the most prominent risk of handling biopsies is the risk of exposure to formalin, Axlab wanted to enter the market as legal manufacturer by creating a simple device that would make it safer and faster for healthcare professionals to handle biopsies. Their first ever Medical Device.
Our task was clear:
1 Create an intuitive Medical Device
2 Have it ready for CE-marking
3 Set up a complete Quality Management System for the company
4 Make ordering new products as easy as pushing a button
The Lay Of The Land
Rising expectations to hospital efficiency and a growing focus on employee safety have fueled the ever increasing need for safer, easier and more efficient procedures for handling biopsies. In line with this reality Axlab wanted to create a new and better way of handling biopsies from retrieving the biopsy to analysis of the biopsy.
Due to the lack of experience with medical device development they also wanted Technolution to help them set up a Quality Management System to ensure that the developed product would meet regulatory requirements and be CE marked.
In partnership with Axlab’s healthcare experts, we codesigned BiopSafe – a biopsy container that never exposes the healthcare professional to the formalin, which completely eliminates the risk of exposure.
Also, the entire user journey has been dramatically simplified, not only reducing multiple handling steps, but also reducing the cost of training and the need for microbiological safety cabinets to remove the dangerous fumes from the formalin.
Lastly, we set up a new Quality Management System to enable easy and agile management of BiopSafe on a daily basis, while complying to ISO13485 and ISO14971 to name a few.
Having obtained CE marking of the device, the knowledge of BiopSafe has quickly grown and
have already helped and protected healthcare professionals out in the field.
The Final Product
View the final product to see how easy and simple and most of all safe handling of biopsies are now. Then find out what the CEO of Axlab has to say about the experience below.
Ole Jacobsen, Axlab CEO:
Development of medical devices is a long and complicated process that Technolution has carried out with great expertise. Technolution’s broad know-how has meant we have a well proven product ready for the market.