Access Norway

Offentlig prosjektsammendrag

Twenty three million women per year have a subdermal contraceptive implant inserted as their chosen method of family planning. Contraceptive implants are small plastic rods inserted under the skin of the upper arm where they provide reversible contraception for 3-5 years before they are removed or replaced. The contraceptive implant has shown unprecedented growth over the past 10 years compared to all other family planning methods. Its uptake is rapidly increasing in many countries, including Norway. The proposed project is the establishment of a clinical investigational collaboration between RemovAid and Sex & Samfunn. RemovAid develop a novel medical device to facilitate contraceptive implant removal. The device fixates the implant, incises the skin at the implant midpoint, and extracts it through the incision using a tweezer. Sex & Samfunn is a private foundation and the larges sexual health clinic nationally. The key challenges to be addressed within the frame of the collaboration include: 1. Assessment of the RemovAid performance in routine clinical use 2. Improvement of the overall success rate through translational device design 3. Exploration of failure modes and use errors through clinical and usability testing 4. Analysis of the routine removal procedure, including training, to create a comparative baseline to which to assess RemovAid device, including training. 5. Analysis of patient flow through the clinic when using the RemovAid, to better understand the programmatic challenges to a potential implementation of the technology on a larger scale RemovAid will in collaboration with Sex & Samfunn solve our remaining product challenges with direct input and in close proximity to the end user.